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Merck & Co., Inc. (MRK) FDA Events

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FDA Events for Merck & Co., Inc. (MRK)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Merck & Co., Inc. (MRK). Over the past two years, Merck & Co., Inc. has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as belzutifan, CAPVAXIVE, Doravirine/Islatravir, ENFLONSIA™, enlicitide, GARDASIL®9, and HB-200. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Merck & Co., Inc.'s Drugs in FDA Review

belzutifan - FDA Regulatory Timeline and Events

belzutifan is a drug developed by Merck & Co., Inc. for the following indication: Treated Patients With Advanced Renal Cell Carcinoma (RCC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CAPVAXIVE - FDA Regulatory Timeline and Events

CAPVAXIVE is a drug developed by Merck & Co., Inc. for the following indication: For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Doravirine/Islatravir - FDA Regulatory Timeline and Events

Doravirine/Islatravir is a drug developed by Merck & Co., Inc. for the following indication: In adults with HIV-1 infection. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

ENFLONSIA™ - FDA Regulatory Timeline and Events

ENFLONSIA™ is a drug developed by Merck & Co., Inc. for the following indication: In Infants Born During or Entering Their First RSV Season. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

enlicitide decanoate - FDA Regulatory Timeline and Events

enlicitide decanoate is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Adults With Hyperlipidemia. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) - FDA Regulatory Timeline and Events

GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) is a drug developed by Merck & Co., Inc. for the following indication: Oropharyngeal and Other Head and Neck Cancers. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

HB-200 + KEYTRUDA (pembrolizumab) - FDA Regulatory Timeline and Events

HB-200 + KEYTRUDA (pembrolizumab) is a drug developed by Merck & Co., Inc. for the following indication: Advanced head and neck cancers. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

HER3-DXd - FDA Regulatory Timeline and Events

HER3-DXd is a drug developed by Merck & Co., Inc. for the following indication: For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

HERTHENA-Lung02 - FDA Regulatory Timeline and Events

HERTHENA-Lung02 is a drug developed by Merck & Co., Inc. for the following indication: In patients with locally advanced or metastaticEGFR-mutated non-small cell lung cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

HRS-5346 - FDA Regulatory Timeline and Events

HRS-5346 is a drug developed by Merck & Co., Inc. for the following indication: For Cardiovascular Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

I-DXd - FDA Regulatory Timeline and Events

I-DXd is a drug developed by Merck & Co., Inc. for the following indication: In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYFORM-007 - FDA Regulatory Timeline and Events

KEYFORM-007 is a drug developed by Merck & Co., Inc. for the following indication: For Patients With Previously Treated PD-L1 Positive Microsatellite Stable Metastatic Colorectal Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYFORM-008 - FDA Regulatory Timeline and Events

KEYFORM-008 is a drug developed by Merck & Co., Inc. for the following indication: For PD-1 relapsed or refractory classical Hodgkin lymphoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYLYNK-001 - FDA Regulatory Timeline and Events

KEYLYNK-001 is a drug developed by Merck & Co., Inc. for the following indication: For people with BRCA non-mutated advanced epithelial ovarian cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYLYNK-006 - FDA Regulatory Timeline and Events

KEYLYNK-006 is a drug developed by Merck & Co., Inc. for the following indication: For the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-483 - FDA Regulatory Timeline and Events

KEYNOTE-483 is a drug developed by Merck & Co., Inc. for the following indication: For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-522 - FDA Regulatory Timeline and Events

KEYNOTE-522 is a drug developed by Merck & Co., Inc. for the following indication: in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-671 - FDA Regulatory Timeline and Events

KEYNOTE-671 is a drug developed by Merck & Co., Inc. for the following indication: Evaluating neoadjuvant KEYTRUDA plus chemotherapy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-689 - FDA Regulatory Timeline and Events

KEYNOTE-689 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-811 - FDA Regulatory Timeline and Events

KEYNOTE-811 is a drug developed by Merck & Co., Inc. for the following indication: reatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-966 - FDA Regulatory Timeline and Events

KEYNOTE-966 is a drug developed by Merck & Co., Inc. for the following indication: anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-A18 - FDA Regulatory Timeline and Events

KEYNOTE-A18 is a drug developed by Merck & Co., Inc. for the following indication: For Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYNOTE-B96 - FDA Regulatory Timeline and Events

KEYNOTE-B96 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Platinum-Resistant Recurrent Ovarian Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KEYTRUDA®(pembrolizumab) - FDA Regulatory Timeline and Events

KEYTRUDA®(pembrolizumab) is a drug developed by Merck & Co., Inc. for the following indication: For the treatment of patients with locally advanced or metastatic urothelial carcinoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KeyVibe-008 - FDA Regulatory Timeline and Events

KeyVibe-008 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Extensive-Stage Small Cell Lung Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

KeyVibe-010 - FDA Regulatory Timeline and Events

KeyVibe-010 is a drug developed by Merck & Co., Inc. for the following indication: Treatment for Patients With Resected High-Risk Melanoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LEAP-015 - FDA Regulatory Timeline and Events

LEAP-015 is a drug developed by Merck & Co., Inc. for the following indication: For Gastroesophageal Adenocarcinoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LINE-007 - FDA Regulatory Timeline and Events

LINE-007 is a drug developed by Merck & Co., Inc. for the following indication: For Diffuse Large B-Cell Lymphoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LINE-010 - FDA Regulatory Timeline and Events

LINE-010 is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LYNPARZA (Olaparib) - FDA Regulatory Timeline and Events

LYNPARZA (Olaparib) is a drug developed by Merck & Co., Inc. for the following indication: BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MK-1084 - FDA Regulatory Timeline and Events

MK-1084 is a drug developed by Merck & Co., Inc. for the following indication: Oral selective KRAS G12C inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MK-1654 - FDA Regulatory Timeline and Events

MK-1654 is a drug developed by Merck & Co., Inc. for the following indication: An Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MK-3475A-D77 - FDA Regulatory Timeline and Events

MK-3475A-D77 is a drug developed by Merck & Co., Inc. for the following indication: For the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MK-7240 - FDA Regulatory Timeline and Events

MK-7240 is a drug developed by Merck & Co., Inc. for the following indication: In Inflammatory Bowel Disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

MK-8527 - FDA Regulatory Timeline and Events

MK-8527 is a drug developed by Merck & Co., Inc. for the following indication: novel nucleoside reverse transcriptase translocation inhibitor. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Molnupiravir (MK-4482) - FDA Regulatory Timeline and Events

Molnupiravir (MK-4482) is a drug developed by Merck & Co., Inc. for the following indication: Covid-19. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NRG-GY018 - FDA Regulatory Timeline and Events

NRG-GY018 is a drug developed by Merck & Co., Inc. for the following indication: Evaluating KEYTRUDA in combination with standard of care chemotherapy (paclitaxel and carboplatin). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NUMELVI™ - FDA Regulatory Timeline and Events

NUMELVI™ is a drug developed by Merck & Co., Inc. for the following indication: for the Treatment of Pruritus Associated with Allergic Dermatitis Including Atopic Dermatitis and Treatment of Clinical Manifestations of Atopic Dermatitis in Dogs. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Restoret™ - FDA Regulatory Timeline and Events

Restoret™ is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Diabetic Macular Edema. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

sac-TMT - FDA Regulatory Timeline and Events

sac-TMT is a drug developed by Merck & Co., Inc. for the following indication: For the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Sotatercept - FDA Regulatory Timeline and Events

Sotatercept is a drug developed by Merck & Co., Inc. for the following indication: Pulmonary Arterial Hypertension (PAH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

sotatercept-csrk - FDA Regulatory Timeline and Events

sotatercept-csrk is a drug developed by Merck & Co., Inc. for the following indication: In adults with pulmonary arterial hypertension. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

V116 (21-valent pneumococcal conjugate vaccine) - FDA Regulatory Timeline and Events

V116 (21-valent pneumococcal conjugate vaccine) is a drug developed by Merck & Co., Inc. for the following indication: Pneumococcal Disease and Pneumococcal Pneumonia in Adults. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

V181 - FDA Regulatory Timeline and Events

V181 is a drug developed by Merck & Co., Inc. for the following indication: for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

V940-001 - FDA Regulatory Timeline and Events

V940-001 is a drug developed by Merck & Co., Inc. for the following indication: for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

waveLINE-003 - FDA Regulatory Timeline and Events

waveLINE-003 is a drug developed by Merck & Co., Inc. for the following indication: In Patients With Relapsed/Refractory DLBCL. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Merck & Co., Inc. FDA Events - Frequently Asked Questions

Yes, Merck & Co., Inc. (MRK) has received FDA approval for multiple therapies, including KEYNOTE-483, NRG-GY018 and CAPVAXIVE. This page tracks recent and historical FDA regulatory events related to Merck & Co., Inc.'s drug portfolio.

In the past two years, Merck & Co., Inc. (MRK) has reported FDA regulatory activity for the following drugs: KEYTRUDA®(pembrolizumab), sotatercept-csrk, belzutifan, KEYNOTE-689, KEYNOTE-483, I-DXd, CAPVAXIVE, Doravirine/Islatravir, ENFLONSIA™, MK-1084, MK-3475A-D77, NRG-GY018, KEYNOTE-671, GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant), MK-1654, KEYNOTE-811, Sotatercept, V116 (21-valent pneumococcal conjugate vaccine), HB-200 + KEYTRUDA (pembrolizumab), MK-8527, NUMELVI™, V181, enlicitide decanoate, waveLINE-003, KEYNOTE-B96, HRS-5346, LINE-010, LEAP-015, KEYFORM-008, KEYLYNK-001, LINE-007, Molnupiravir (MK-4482), sac-TMT, MK-7240, KEYFORM-007, HERTHENA-Lung02, KEYLYNK-006, KEYNOTE-A18, Restoret™, LYNPARZA (Olaparib), KeyVibe-008, HER3-DXd, KEYNOTE-522, V940-001, KEYNOTE-966 and KeyVibe-010.

The most recent FDA-related event for Merck & Co., Inc. occurred on July 10, 2025, involving Doravirine/Islatravir. The update was categorized as "FDA review," with the company reporting: "Merck announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for doravirine/islatravir (DOR/ISL), an investigational, once-daily, oral, two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy."

Current therapies from Merck & Co., Inc. in review with the FDA target conditions such as:

  • For the treatment of patients with locally advanced or metastatic urothelial carcinoma - KEYTRUDA®(pembrolizumab)
  • In adults with pulmonary arterial hypertension - sotatercept-csrk
  • Treated Patients With Advanced Renal Cell Carcinoma (RCC) - belzutifan
  • In Patients With Resected, Locally Advanced Head and Neck Squamous Cell Carcinoma - KEYNOTE-689
  • For the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. - KEYNOTE-483
  • In patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). - I-DXd
  • For the prevention of invasive disease caused by Streptococcus pneumoniae serotypes - CAPVAXIVE
  • In adults with HIV-1 infection - Doravirine/Islatravir
  • In Infants Born During or Entering Their First RSV Season - ENFLONSIA™
  • Oral selective KRAS G12C inhibitor - MK-1084
  • For the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC). - MK-3475A-D77
  • Evaluating KEYTRUDA in combination with standard of care chemotherapy (paclitaxel and carboplatin) - NRG-GY018
  • Evaluating neoadjuvant KEYTRUDA plus chemotherapy - KEYNOTE-671
  • Oropharyngeal and Other Head and Neck Cancers - GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
  • An Investigational Respiratory Syncytial Virus Preventative Monoclonal Antibody for Infants - MK-1654
  • reatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma. - KEYNOTE-811
  • Pulmonary Arterial Hypertension (PAH) - Sotatercept
  • Pneumococcal Disease and Pneumococcal Pneumonia in Adults - V116 (21-valent pneumococcal conjugate vaccine)
  • Advanced head and neck cancers - HB-200 + KEYTRUDA (pembrolizumab)
  • novel nucleoside reverse transcriptase translocation inhibitor - MK-8527
  • for the Treatment of Pruritus Associated with Allergic Dermatitis Including Atopic Dermatitis and Treatment of Clinical Manifestations of Atopic Dermatitis in Dogs - NUMELVI™
  • for the prevention of dengue disease caused by any of the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) - V181
  • For the Treatment of Adults With Hyperlipidemia - enlicitide decanoate
  • In Patients With Relapsed/Refractory DLBCL - waveLINE-003
  • In Patients With Platinum-Resistant Recurrent Ovarian Cancer - KEYNOTE-B96
  • For Cardiovascular Disease - HRS-5346
  • For the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma - LINE-010
  • For Gastroesophageal Adenocarcinoma - LEAP-015
  • For PD-1 relapsed or refractory classical Hodgkin lymphoma. - KEYFORM-008
  • For people with BRCA non-mutated advanced epithelial ovarian cancer - KEYLYNK-001
  • For Diffuse Large B-Cell Lymphoma - LINE-007
  • Covid-19 - Molnupiravir (MK-4482)
  • For the Treatment of Certain Patients With Previously Treated Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer With EGFR Mutations - sac-TMT
  • In Inflammatory Bowel Disease - MK-7240
  • For Patients With Previously Treated PD-L1 Positive Microsatellite Stable Metastatic Colorectal Cancer - KEYFORM-007
  • In patients with locally advanced or metastaticEGFR-mutated non-small cell lung cancer - HERTHENA-Lung02
  • For the first-line treatment of certain patients with metastatic nonsquamous non-small cell lung cancer (NSCLC). - KEYLYNK-006
  • For Patients With Newly Diagnosed High-Risk Locally Advanced Cervical Cancer - KEYNOTE-A18
  • For the Treatment of Diabetic Macular Edema - Restoret™
  • BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer - LYNPARZA (Olaparib)
  • In Patients With Extensive-Stage Small Cell Lung Cancer - KeyVibe-008
  • For the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) - HER3-DXd
  • in Patients With High-Risk Early-Stage Triple Negative Breast Cancer (TNBC) - KEYNOTE-522
  • for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma - V940-001
  • anti-PD-1 therapy, in combination with standard of care chemotherapy (gemcitabine and cisplatin) - KEYNOTE-966
  • Treatment for Patients With Resected High-Risk Melanoma - KeyVibe-010

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process
Stock Lists
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This page (NYSE:MRK) was last updated on 7/13/2025 by MarketBeat.com Staff
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