medtechdive4h
Device industry scrambles as FDA job cuts cause delays
The cuts at the FDA’s device center could add “months, if not years” to the time it takes to bring products to market, an ...
STAT7d
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 ...
Trump administration cuts reach FDA employees in food safety, medical devices and tobacco products
The Trump administration’s effort to slash the size of the federal workforce reached the Food and Drug Administration this ...
Chemomab completes End-of-Phase 2 Meeting with the FDA for CM-101
Chemomab Therapeutics (CMMB) announced the successful completion of its End-of-Phase 2 Meeting with the FDA and alignment with FDA on the ...
Drug industry: Let us make Americans healthy
Drug company executives on Tuesday touted their industry’s work to keep and make Americans healthy during a Washington event.
Benzinga.com6d
Small-Cap OS Therapies Inks Commercial Manufacture Agreements For Lead Cancer Drug For Rare Type Of Bone Cancer
OS Therapies signed agreements for the commercial manufacture of OST-HER2 as it prepares for an FDA meeting and potential BLA submission. Phase 2b data show OST-HER2 significantly improved 12 ...
PMGC submits pre-IND meeting request to FDA for EL-22 in obesity
Northstrive Biosciences has submitted a pre-Investigational New Drug, or pre-IND, meeting request to the FDA for EL-22, a novel myostatin asset ...
Yahoo Finance6d
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings
Ryoncil ® was approved in December 2024 by the United States Food and Drug Administration (FDA) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months ...
Investing6d
OS Therapies gears up for FDA meeting on cancer drug
The drug has already garnered rare pediatric disease ... As the company prepares for its regulatory meetings, the healthcare community and investors are watching closely for the potential impact ...