FDA Events for Dr. Reddy's Laboratories (RDY)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Dr. Reddy's Laboratories (RDY).
Over the past two years, Dr. Reddy's Laboratories has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DRL_RI, DRL-1801, HLX15, and Lenalidomide. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
DRL_RI - FDA Regulatory Timeline and Events
DRL_RI is a drug developed by Dr. Reddy's Laboratories for the following indication: For the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
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.
- Drug:
- DRL_RI
- Announced Date:
- July 29, 2024
- Indication:
- For the treatment of adult patients with rheumatoid arthritis, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Announcement
Dr. Reddy's Laboratories Ltd. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the launch of its proposed biosimilar Rituximab candidate DRL_RI (ITUXREDI®) in European markets.
AI Summary
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its proposed biosimilar Rituximab candidate, DRL_RI (ITUXREDI®). This recommendation supports the launch of ITUXREDI® in European markets, with the biosimilar intended to mirror the approved uses of MabThera®, including treatments for Non–Hodgkin’s Lymphoma, Chronic Lymphocytic Leukaemia, Rheumatoid Arthritis, and specific autoimmune conditions.
The CHMP’s positive opinion will now be reviewed by the European Commission, which will decide on marketing authorisation for EU and select European Economic Area countries. Dr. Reddy’s already secured an EU GMP certificate for its manufacturing facility in Hyderabad, India, underscoring its commitment to quality and safety as it expands its portfolio of biosimilar products aimed at increasing global access to affordable treatments.
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DRL-1801 - FDA Regulatory Timeline and Events
DRL-1801 is a drug developed by Dr. Reddy's Laboratories for the following indication: For Novel Autologous CAR-T Cell Therapy for Multiple Myeloma.
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.
- Drug:
- DRL-1801
- Announced Date:
- October 8, 2024
- Indication:
- For Novel Autologous CAR-T Cell Therapy for Multiple Myeloma
Announcement
Aurigene Oncology Limited, a wholly-owned subsidiary of Dr. Reddy's Laboratories announced the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study – India's first trial for a novel autologous BCMA directed CAR-T cell therapy in patients with relapsed / refractory multiple myeloma.
AI Summary
Aurigene Oncology Limited, a subsidiary of Dr. Reddy’s Laboratories, announced promising Phase 1 results for Ribrecabtagene autoleucel (DRL-1801) from the SWASTH study—India’s first trial of an autologous BCMA-directed CAR-T cell therapy for relapsed or refractory multiple myeloma. The trial involved eight patients who had undergone a median of 5.5 prior treatment lines, with most having experienced disease progression after a transplant.
All patients achieved a clinical response, and 62.5% reached a stringent complete response. Importantly, the treatment showed a favorable safety profile with no high-grade cases of cytokine release syndrome or neurotoxicity reported. Following this encouraging data, the Drugs Controller General of India (DCGI) has given approval to advance to Phase 2 of the trial. These findings provide renewed hope for more effective treatment options for patients battling advanced multiple myeloma.
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HLX15 - FDA Regulatory Timeline and Events
HLX15 is a drug developed by Dr. Reddy's Laboratories for the following indication: a biosimilar candidate to Darzalex® & Darzalex Faspro®.
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.
- Drug:
- HLX15
- Announced Date:
- February 6, 2025
- Indication:
- a biosimilar candidate to Darzalex® & Darzalex Faspro®
Announcement
Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy's Laboratories Ltd. announced that it has entered into a license agreement with Shanghai Henlius Biotech, Inc. (2696.HK) related to the development and commercialization of HLX15, Henlius's investigational daratumumab biosimilar candidate to Darzalex® & Darzalex Faspro®.
AI Summary
Dr. Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., has entered into a license agreement with Shanghai Henlius Biotech, Inc. for the development and commercialization of HLX15. HLX15 is Henlius’s investigational biosimilar candidate to Darzalex® and Darzalex Faspro®, and it is available in both intravenous and subcutaneous formulations. The agreement grants Dr. Reddy’s exclusive rights to market HLX15 in the United States and Europe. Under the terms, Henlius is responsible for the development, manufacturing, and commercial supply of HLX15, with potential payments totaling up to $131.6 million through upfront and milestone payments, along with eligibility for royalties based on annual net sales. This collaboration leverages Dr. Reddy’s global commercial presence and Henlius’s established biosimilar development capabilities to improve patient access to advanced oncology therapies.
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Lenalidomide Capsules - FDA Regulatory Timeline and Events
Lenalidomide Capsules is a drug developed by Dr. Reddy's Laboratories for the following indication: Multiple myeloma and myelodysplastic syndrome.
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.
- Drug:
- Lenalidomide Capsules
- Announced Date:
- February 19, 2025
- Indication:
- Multiple myeloma and myelodysplastic syndrome
Announcement
Amneal Pharmaceuticals announced that the Company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths.
AI Summary
Amneal Pharmaceuticals recently announced that it has received FDA approval for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. This approval means that the company can now offer a generic version of lenalidomide, a thalidomide analogue used for treating several types of blood cancers. Amneal’s milestone is supported by a settlement agreement with Celgene, which licenses the necessary patents to manufacture and sell the generic drug in the U.S. starting January 31, 2026. The FDA clearance underlines the Company’s strong research and development capabilities and its commitment to expanding its portfolio of affordable medicines in competitive markets. Such innovations are expected to drive future growth and provide patients with access to vital treatments.
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