FDA Approval Propels ZVRA To 52-week High, ADMA, CPRX, TVTX Also Reach New Peaks
Zevra Therapeutics Inc. (ZVRA) made headlines yesterday with a landmark FDA approval for its innovative drug, MIPLYFFA, in the ...
FDA approves first self-administered flu vaccine spray
The Food and Drug Administration announced Friday it had broadened the approval of the FluMist nasal spray to become the ...
FDA approves first flu vaccine that can be self-administered at home
The US Food and Drug Administration on Friday approved the first flu vaccine that does not have to be administered by a ...
STAT2d
FDA approves first drug for rare neuron disease, Niemann-Pick type C
Parents pushed for years for treatments for the neuron disease Niemann-Pick type C. After setbacks, one drug now has FDA ...
The Korea Times on MSN2d
REDNVIA eyes US market with repurposed drug for heart valve disorder
Creating a novel drug has always been a risky endeavor for biopharmaceutical companies. Developers and investors face ...
Ozempic: GLP-1 Drugs May Help Prevent 34,000 Heart Attacks and Strokes Per Year
GLP-1 drugs like Ozempic and Wegovy may help reduce the risk of cardiovascular disease and prevent more than 34,000 heart ...
Opinion
Abortion deaths: It’s not the bans. It’s the doctors
The villain in this tale, is not the so-called “abortion ban.” It’s the Food and Drug Administration, the clinic, and the doctors.
JD Supra4d
FDA and the Fountain of Youth: Regulatory Hurdles in the Longevity Biotech Community
With every major advancement in the field of aging biology, humankind is one step closer to turning back the clock and restoring our youth. In ...
Neuralink Brain Implant Wins an FDA Nod to Tackle Blindness
The regulatory approval is just the first phase of a long project, but Neuralink owner Elon Musk is already touting his brain ...
FierceBiotech4d
FDA scraps adcomm for Applied's rare disease drug ahead of November decision
After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided ...
Medscape4d
FDA Faces Blowback Over Stricter Regulation of Lab-Developed Tests
Clinical laboratory lobbying groups are suing the FDA over its plans to more strictly regulate lab-developed tests. For now, ...
Generics, patient groups train ire on patent bills
The Senate Judiciary Committee is scheduled to mark up two bipartisan bills Thursday that affordable-drug proponents and generics makers say would make it easier for major pharma companies to game the ...