STAT1d
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
Travere Therapeutics stock soars on FDA meeting outcome
Shares of Travere Therapeutics (NASDAQ:TVTX) surged 14% Tuesday following the company's announcement of a successful Type C ...
STAT1d
Pharmalittle: We’re reading about FDA morale, pharma removing DEI goals, and more
Reports of impending layoffs, a buyout offer, and a return-to-office mandate have put a damper on FDA staff morale ...
FDA pauses updates on foodborne outbreak probes as health agencies regroup on communications
The Trump administration's "short pause" on communications, expected to end on Feb. 1, has affected FDA updates on food ...
FDA Grants Fast-Track Designation To Cannabis Withdrawal Syndrome Drug
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...
Trump's freeze on health agency communications leads to cancellation of scientific meetings
The Trump administration’s freeze on communications from U.S. health agencies is leading to another disruption: the abrupt cancellation of scientific meetings. The move covers a swath of health ...
MedPage Today2hOpinion
REMS for Clozapine Must Go
FDA convened a joint meeting of its Drug Safety and Risk Management Advisory Committee and the Psychopharmacologic Drugs ...
JD Supra29d
FDA announces public meeting on pediatric exclusivity and drug development
Earlier this month, the U.S. Food and Drug Administration (FDA) announced a public meeting entitled “Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and ...
JD Supra8d
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
federalnewsnetwork.com16d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
London South East25d
Update on FDA Pre-IND Meeting for Awakn
Awakn announced a positive outcome from a Pre-Investigational New Drug ("Pre-IND") meeting with the U.S. Food and Drug Administration ("FDA") regarding AWKN-002, a proprietary oral thin film ("OTF ...