FDA nominee sidesteps questions on abortion pill, agency layoffs and other issues
A professor at Johns Hopkins University, Makary is known for his contrarian views and previously called the FDA “broken,” and ...
BioSpace8h
FDA Action Alert: GSK, Alnylam, Sanofi and More
One of the most highly anticipated FDA decisions this month is for Alnylam Pharmaceuticals, which is seeking to expand the ...
Endpoints News1h
Min­eralys’ Phase 3 blood pres­sure pill da­ta sup­port po­ten­tial FDA ap­proval
Mineralys Therapeutics' lorundrostat shows promising Phase 3 results in treating resistant hypertension, with 9.1 mmHg blood ...
FDA's Proposed Nicotine Rule: Communicating Harm Reduction In Times Of Policy Change
For communications leaders across industries, this initiative underscores the critical importance of crafting clear messaging ...
Dexcom receives FDA warning letter for two U.S. manufacturing facilities
Medical device maker Dexcom said it has received a warning letter from the U.S. Food and Drug Administration following ...
DexCom Gets FDA Warning Letter After Inspections of Facilities
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
A Spending Freeze at the FDA Threatens Safety of Food Supply, Current Staffers Say
FDA staffers tell CR how the suspension of their discretionary spending is threatening the safety of the American food supply ...
National Law Review10h
FDA Issues FSVP-Related Warning Letters
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Amazon Cookie Recall Elevated To FDA’s Deadliest Category—Is It A Risk?
The Amazon Fresh cookie recall is an FDA Class I recall due to undeclared egg allergens. Here’s why it took time to surface and if it may still poses a risk.
California biotech company gets FDA approval for EpiPen alternative for kids
Parents and pediatricians just gained one more tool to combat severe allergic reactions in young kids. San Diego-based ARS ...
The Daily Signal11h
FDA Nominee Makary Calls for ‘More Humility in the Medical Establishment’
Dr. Makary argues for more humility from the medical establishment and common sense when reviewing experimental drugs for ...