This story was originally published on PharmaVoice. To receive daily news and insights, subscribe to our free daily PharmaVoice newsletter. The FDA is pushing for faster drug reviews with an ...

SAN DIEGO, June 9, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide ...

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, ...

FDA confirmed that eGFR slope is an acceptable surrogate endpoint for accelerated approval of rilparencel in patients with CKD and type 2 diabetesFDA also confirmed that the ongoing Phase 3 PROACT 1 ...

The HHS Office of Inspector General report emphasizes the need for better documentation and oversight in the FDA's accelerated approval pathway. The accelerated approval pathway is crucial for ...

Investing.com -- Inovio Pharmaceuticals Inc (NASDAQ:INO) stock plunged 21% Monday after the FDA raised concerns about the company’s accelerated approval pathway for its RRP treatment candidate.

(RTTNews) - ProKidney Corp. (PROK) Tuesday said it has secured alignment with the U.S. Food and Drug Administration (FDA) on the accelerated approval pathway for rilparencel. The FDA confirmed that ...

PRINCETON, N.J. - PDS Biotechnology Corporation (NASDAQ:PDSB) announced Tuesday that the FDA has accepted its request for a Type C Meeting scheduled to occur this month to discuss a proposed ...

Investing.com -- ProKidney Corp (NASDAQ:PROK) stock jumped as high as 12% after the company announced that the U.S. Food and Drug Administration (FDA) has confirmed an accelerated approval pathway for ...