FierceBiotech

FDA delays decision on Biohaven's rare disease drug filing, plans adcomm

Biohaven is giving investors whiplash. Forty-eight hours after saying its filing was on track, the biopharma revealed the FDA has delayed an approval decision on its rare disease candidate troriluzole ...
JD Supra

FDA’s Rare Disease Evidence Principles Process Provides Guidance for Applications Supported by a Single Pivotal Trial

On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence ...
JD Supra

Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process

On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ and distributors’ awareness and understanding of the FDA’s new ...
RAPS

FDA Guidance Sets Up Voluntary New IDE Submission Process Aimed at Correcting Deficiencies

US regulators today released a new draft guidance document that looks to clarify the US Food and Drug Administration's (FDA) expectations when it comes to approving an investigational device exemption ...
Hosted on MSN

SRRK stock jumps on resubmission of FDA filing for SMA drug

Shares of Scholar Rock SRRK rose 14% on Tuesday after the company announced the resubmission of a regulatory filing to the FDA, seeking approval for its investigational muscle-targeted therapy, ...
Vietnam Investment Review on MSN

C Ray Therapeutics receives FDA acceptance for copper 64 file

CHENGDU, China, April 28, 2026 /PRNewswire/ -- C-Ray Therapeutics (Chengdu) Co., Ltd., today announced that its Type II Drug Master File (DMF) for COPPER [64Cu] CHLORIDE FOR RADIOLABELLING has been ...