Judge tells CDC, FDA, HHS to restore webpages and data removed after Trump’s executive order
A federal judge on Tuesday ordered government agencies to restore public access to health-related webpages and datasets that ...
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, ...
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 ...
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 GOMEKLI™ (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 ...
Contract Pharma1h
OnCusp’s CUSP06 Receives FDA Fast Track Designation
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06, a Cadherin-6 targeting ...
FDA approves pig organ transplant trials for patients with kidney failure
The first clinical trials using organs from genetically modified pigs offer hope to patients with kidney failure, who face a ...
JD Supra6d
FDA’s Rare Disease Innovation Hub Releases Strategic Agenda: Implications for Stakeholders in 2025
including CDER’s ARC Program and CBER’s Rare Disease Program, as well as the perennial FDA focal point for rare disease, the Office of Orphan Products. While stakeholders have called for ...
Firefly Neuroscience Accepted into NVIDIA Connect Program
Collaboration to provide Firefly with the technical resources to help further unleash the power of its FDA-cleared BNA™ platform For the ...