Cogent Biosciences stock climbs after FDA accepts key drug application

Cogent Biosciences Inc. COGT shares are up on Monday after the U.S. Food and Drug Administration accepted its drug ...

NRx Pharma stock jumps after FDA signals path to NDA for ketamine depression drug

NRx Pharmaceuticals Inc. NRXP shares are surging on Monday following positive developments regarding its New Drug Application ...

Biotech Stocks Rally on Departure of Polarizing FDA Official

Biotech investors have rarely united so strongly against a Food and Drug Administration official as they did against Vinay ...

What's Going On With Moderna, Capricor, Other Biotech Stocks On Monday?

The U.S. Food and Drug Administration Commissioner Marty Makary confirmed on Friday that Dr. Vinay Prasad, head of its Center ...

Biotech Stock Up 685% Draws $80.5 Million Investment Amid Dual FDA Filings

Praxis Precision Medicines focuses on clinical-stage therapies for central nervous system disorders, targeting unmet needs in neurology.
Nasdaq

Biotech Stocks Facing FDA Decision In March 2026

(RTTNews) - As we head into the final month of the first quarter, it's time to take stock of the regulatory landscape. But before we turn to the upcoming FDA decisions, here are some of the regulatory ...

Biotech firm stocks rise on FDA vaccine head’s exit

Shares of certain biotech firms were rising ahead of market open on Monday on news of the departure of the FDA’s vaccine ...
BioSpace

Prasad Out at FDA, Lawmaker Takes Action on Rare Disease Rejections and a Spate of Obesity Data

Rare disease biotech stocks pop on the news that Vinay Prasad, the FDA’s chief biologics regulator, will depart the FDA at the end of April; Sen. Ron Johnson launches an investigation into recent rare ...
Blockonomi

Novo Nordisk (NVO) Stock Falls 27% After FDA Warning on Unreported Semaglutide Adverse Events

Novo Nordisk (NVO) stock dropped 27% YTD after FDA warning letter cited failure to report semaglutide side effects, including ...

UniQure stock plunges after FDA rejects gene therapy data, Sell-side Comments

UniQure NV (NASDAQ:QURE) shares tumbled 36% after the U.S. Food and Drug Administration informed the company that data from its early- to mid-stage trial of AMT-130, a gene therapy for Huntington’s ...