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 ...
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 ...
Cure Today8d
Breaking Down Cancer Therapies Approved by the FDA in January 2025
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JD Supra12d
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
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FDA Leads Seven African Regulators to Foster Trust and Accelerate Access to Medicines
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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, ...
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Supernus wins FDA approval for Parkinson’s pump on fourth try
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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 ...
Linvoseltamab BLA Accepted for FDA Review for the Treatment of Relapsed/Refractory Multiple Myeloma
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With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
People13d
FDA Approves Ozempic to Treat Kidney Disease
The FDA’s new approval makes the drug the first GLP-1 ... senior vice president of clinical development, medical & regulatory affairs for Novo Nordisk, maker of Ozempic — in a press release.