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Roivant Sciences (ROIV) FDA Events

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FDA Events for Roivant Sciences (ROIV)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Roivant Sciences (ROIV). Over the past two years, Roivant Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Mosliciguat and VTAMA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Roivant Sciences' Drugs in FDA Review

Mosliciguat - FDA Regulatory Timeline and Events

Mosliciguat is a drug developed by Roivant Sciences for the following indication: In PH patients. 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.

VTAMA (tapinarof) cream - FDA Regulatory Timeline and Events

VTAMA (tapinarof) cream is a drug developed by Roivant Sciences for the following indication: Plaque psoriasis. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Roivant Sciences FDA Events - Frequently Asked Questions

Yes, Roivant Sciences (ROIV) has received FDA approval for VTAMA (tapinarof) cream. This page tracks recent and historical FDA regulatory events related to Roivant Sciences' drug portfolio.

In the past two years, Roivant Sciences (ROIV) has reported FDA regulatory activity for the following drugs: VTAMA (tapinarof) cream and Mosliciguat.

The most recent FDA-related event for Roivant Sciences occurred on December 16, 2024, involving VTAMA (tapinarof) cream. The update was categorized as "FDA Approval," with the company reporting: "Organon announced that the U.S. Food and Drug Administration (FDA) has approved VTAMA® (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis (AD) in adults and pediatric patients 2 years of age and older.1"

Current therapies from Roivant Sciences in review with the FDA target conditions such as:

  • Plaque psoriasis - VTAMA (tapinarof) cream
  • In PH patients. - Mosliciguat

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

This page (NASDAQ:ROIV) was last updated on 7/10/2025 by MarketBeat.com Staff
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