US FDA expands approval for Alnylam's drug to treat rare heart disease
U.S. Food and Drug Administration approved Alnylam's drug to treat a rare and deadly heart disease on Thursday, allowing the ...
Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights
August 15, 2025, is the FDA PDUFA goal date for TNX-102 SL for the management of fibromyalgia; If approved, TNX-102 SL would become the first new ...
Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...
MPR3d
FDA Determines REMS No Longer Necessary for Tryvio
The Tryvio REMS program was established due to the risk of birth defects associated with the ERA drug class. Prior to dispensing Tryvio, patients of reproductive potential were required to report a ...
FDA Reinstates Fired Probationary Workers After Judge's Order
The FDA is reinstating fired probationary workers after a federal judge ruled their terminations were unlawful and must be ...
CURE3d
FDA Grants Orphan Drug Designation to PEP-010 in Pancreatic Cancer
The FDA has granted orphan drug designation to PEP-010 for pancreatic cancer, advancing its development as a potential novel ...
dvm3603d
FDA conditionally approves first drug for feline subclinical hypertrophic cardiomyopathy
Sirolimus, the active ingredient in Felycin-CA1, at a higher dose is used as an immunosuppressant in human patients receiving ...
Florida Politics8dOpinion
Mark Baughman: The hidden dangers of compounded medicines — a call for caution
These medications are not FDA-approved, meaning they do not undergo the rigorous testing for safety, effectiveness, and ...
Healio8d
FDA grants fast track designation to X-linked retinoschisis treatment
The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release ...
RFK Jr. wants to eliminate FDA’s controversial food additive program. Here’s why that matters
It’s time to revamp the FDA’s “generally recognized as safe,” or GRAS, program that allows companies to add untested ...
Santa Clara County Public Health Officer Dr. Sara Cody, who led pandemic response, to retire after 26 years
Five years after the World Health Organization declared the COVID-19 outbreak a global pandemic, Dr. Sara Cody — the Santa ...