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FDA Refuses Filing of Moderna BLA for Flu Vaccine

[ Price : $8.95]

FDA issues Moderna a refusal-to-file letter on its BLA for an investigational seasonal influenza vaccine mRNA-1010, despite the co...

FDA Cites 2 Argenx TV ads for Vyvgart Hytrulo

[ Price : $8.95]

FDA issues two untitled letters to Argenx, alleging that separate direct-to-consumer television advertisements for Vyvgart Hytrulo...

Aurobindos Eugia Pharma Unit Cited After FDA Inspection

[ Price : $8.95]

Aurobindo Pharma says that FDA has completed an inspection of wholly owned subsidiary Eugia Pharma Specialities in Pashamylaram, T...

FDA Flags Novo Nordisk Over Misleading Wegovy TV Spot

[ Price : $8.95]

FDA tells Novo Nordisk that a new direct-to-consumer television ad for the newly launched Wegovy (semaglutide) oral weight-loss pi...

Regenxbio Gets Complete Response for Gene Therapy

[ Price : $8.95]

FDA issues Regenxbio a complete response letter on its BLA seeking accelerated approval for RGX-121 (clemidsogene lanparvovec), a ...

Compounding Group Questions Thyroid Extract Classification

[ Price : $8.95]

The Alliance for Pharmacy Compounding petitions FDA asking that it reverse its classification of desiccated thyroid extract as a b...

FDA Clears Medians AI Lung Cancer Screener

[ Price : $8.95]

FDA clears a Median Technologies 510(k) for eyonis LCS, the first artificial intelligencebased device cleared for both detection a...

Partial Agreement in PDUFA Talks on Regulatory Science

[ Price : $8.95]

FDA drug regulators and pharmaceutical industry representatives reach a partial agreement on drug development tools, including bio...

BIO Urges Broader Guidance on Monoclonal Antibody Safety Testing

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The Biotechnology Innovation Organization urges FDA to broaden application of its draft guidance on Monoclonal Antibodies: Streaml...

Hims & Hers Scraps Compounded GLP-1 Pill Program

[ Price : $8.95]

Faced with increasing FDA scrutiny and litigation threats from Novo Nordisk, Hims & Hers abruptly shelves its GLP 1 weight loss pi...