This meeting request is in line with previous guidance and BioCardia expects to have the meeting during this quarter. The meeting will be held under BioCardia’s FDA Breakthrough Designation for the ...

Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway Company plans to submit ...

Shares of Agios Pharmaceuticals AGIO rallied 14% on Tuesday after the company announced its intention to seek accelerated ...

Agios Pharmaceuticals (NASDAQ:AGIO) shares climbed about 12% on Tuesday after the company reported progress toward a ...

FDA confirmed givastomig’s potential eligibility for an accelerated approval pathwayNovaBridge expects to initiate a ...

FDA accepts INO-3107 BLA with PDUFA Oct 30, 2026; ORR data, cash runway, and pipeline risks—click to read more now.

SALT LAKE CITY, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene” or the “Company”) and its wholly owned subsidiary Clene Nanomedicine, Inc., a late ...

CB-011, an allogeneic CAR T product, received RMAT designation as treatment for multiple myeloma based on strong dose ...

This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. When Sarepta Therapeutics revealed this month that a ...

Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...

The young drugmaker's sickle cell treatment is receiving special consideration from the United States' top drug regulator.

Please provide your email address to receive an email when new articles are posted on . Most oncology drugs that received FDA accelerated approval between 2011 and 2020 required postmarketing safety ...