US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on ...
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 ...
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Super Bowl ad for Hims & Hers' weight loss drug sparks backlash
The ad goes on to tout Hims & Hers' weight loss drugs as less expensive alternatives to medications like Ozempic and Wegovy, ...
JD Supra12d
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 ...
Healthcare Dive14h
A new, non-opioid pain drug is here. Getting it to patients could be agony.
After decades of research, Vertex Pharmaceuticals now has an approved pain medication. Can one of the world’s most powerful ...
Asianet Newsable on MSN14h
Travere Therapeutics Sparks Retail Frenzy As Stock Hits Over 2-Year High On FDA Approval Plan For Kidney-Disease Drug
Shares of Travere Therapeutics Inc. surged over 13% Tuesday afternoon, reaching their highest level since October 2022 and ...
BioSpace1d
AbbVie Gets FDA Approval for New Antibiotic in the Face of Rising Resistance
The intravenous antibiotic Emblaveo, a combination of aztreonam and avibactam approved in Europe last year, was developed in ...
CURE20h
FDA Approval of Calquence Combo Brings Optimism in MCL
Dr. Tycel Phillips discusses the implications of the FDA approval of Calquence plus bendamustine and Rituxan in untreated MCL ...
Nature12d
US drug agency approves potent painkiller — the first non-opioid in decades
The FDA’s nod for suzetrigine bolsters confidence in the pharmaceutical industry’s strategy to target sodium channels.
Endocrinology Advisor1d
FDA Approves Tocilizumab Biosimilar Avtozma
The FDA has approved Avtozma® (tocilizumab-anoh), a biosimilar to Actemra®, in both intravenous and subcutaneous formulations.