Market Flux Event
FDA Clears COVID Vaccines From Pfizer-BioNTech and Moderna for 2026-2027 Season as Priovant Wins Dermatomyositis Approval
The FDA delivered a cluster of drug approvals on August 27, 2026. Pfizer and BioNTech received approval for an updated XFG-adapted formulation of Comirnaty for the 2026-2027 COVID-19 season, following FDA guidance to match the vaccine to currently circulating SARS-CoV-2 strains. The prior season's Comirnaty had targeted the LP.8.1 sublineage and was approved on August 27, 2025.
Moderna separately received approval earlier the same day for its own updated 2026-2027 formulas covering both Spikevax and mNEXSPIKE. In a distinct approval, Priovant Therapeutics, a company backed by Roivant Sciences, won FDA clearance for Lisraya, a treatment for dermatomyositis, a rare inflammatory condition affecting the skin and muscles that afflicts approximately 50,000 adults in the United States. The drug, known generically as brepocitinib, had received Priority Review after Priovant submitted its new drug application in early 2026 following positive Phase 3 trial results.
Adicet Bio also announced FDA clearance of an investigational new drug application for ADI-212 on the same day.
© AI-generated summary is provided by Market Flux
Sources
- InvestingFDA approves Priovant’s Lisraya for dermatomyositis treatment
- ReutersUS FDA approves Roivant-Priovant's skin and muscle disease drug
- Seeking AlphaModerna gains approval for updated COVID-19 vaccines
- FaststocknewssFDA APPROVES PFIZER $PFE AND BIONTECH $BNTX XFG-ADAPTED COVID VACCINE The XFG adaptation follows FDA guidance on matching the vaccine to circulating SARS-CoV-2 strains. Last season's Comirnaty formula targeted the LP.8.1 sublineage and was approved on August 27, 2025. Moderna $MRNA said earlier today the FDA approved its own 2026-2027 formulas for Spikevax and mNEXSPIKE.
- reuters.comUS FDA approves updated COVID vaccines for 2026-27 season
- CnbcFDA approves daily HIV pill from Gilead designed to simplify treatment for some patients
- seekingalpha.comRevolution Medicines, Inc. (RVMD) Discusses FDA Approval of RASONQUE for Metastatic Pancreatic Cancer and Implications for RAS-Driven Therapy Transcript