Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
The American Journal of Managed Care2h
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
JD Supra4d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
FiercePharma4h
Pfizer's Braftovi combo on track for full approval in win for FDA's Project FrontRunner
Less than two months after an accelerated approval from the FDA, a drug combination featuring Pfizer’s Braftovi has turned in ...
Vertex Pharmaceuticals Just Won a Huge FDA Approval. Is the Biotech Stock a No-Brainer Buy?
Vertex Pharmaceuticals (NASDAQ: VRTX) just snagged its second U.S. Food and Drug Administration (FDA) approval in only 41 ...
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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.
Day One Biopharmaceuticals: A Successful Launch In Pediatric Cancer
Day One Biopharma's OJEMDA FDA approval for pediatric glioma, but market concerns remain. Check out why I rate DAWN stock as ...
JD Supra27d
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics ...
This Stock Just Doubled in 1 Day -- Is It Still a Buy?
Unsurprisingly, Akero owes this incredible one-day gain to data from a midstage clinical trial. Akero Therapeutics is ...
Verywell Health on MSN5d
New Maintenance Dosing Option for Alzheimer's Drug Leqembi Offers Flexibility
The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...
Spur Therapeutics Announces Successful End-of-Phase 2 Meeting with FDA for FLT201, Its Gene Therapy Candidate for Gaucher Disease
FDA aligned on single-arm Phase 3 study to support potential accelerated and full approval On track to dose first patient in Phase 3 trial in second half of 2025 LONDON, Feb. 03, 2025 (GLOBE NEWSWIRE) ...