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FiercePharma
2 小时
FDA warning letter reveals quality control, data integrity issues at Viatris plant in India
In a warning letter posted online late last month, the FDA scolded Viatris over a range of production slights at the ...
FiercePharma
3 小时
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
FiercePharma
4 小时
Pfizer, PhRMA rank among groups pledging funding for Trump's inauguration: NYT
From condemning the Jan. 6 Capitol riots to helping fund the President-elect’s impending inauguration, recent years have seen ...
FiercePharma
7 小时
In €500M deal, Merck buys Ireland vaccines plant from CDMO WuXi Biologics
In Ireland, WuXi Biologics has sold a new vaccines plant to Merck & Co. for €500 million ($521 million). The New Jersey ...
FiercePharma
7 小时
Citius Oncology weighs strategic options on road to launching newly-approved lymphoma med
After nabbing an FDA approval last summer for its T-cell lymphoma treatment Lymphir, Citius Oncology is eyeing strategic ...
FiercePharma
8 小时
‘Ozempic’s biggest night’: GLP-1s back in Hollywood spotlight at Lilly-backed 2025 ...
Comedian Nikki Glaser, host of the 2025 Golden Globe Awards ceremony, dove right in at the start of her opening monologue: ...
FiercePharma
8 小时
Amylyx names chief commercial officer as GLP-1 receptor antagonist launch plans start ...
Amylyx Pharmaceuticals has named Dan Monahan as chief commercial officer, positioning an exec who led the U.S.
FiercePharma
8 小时
Regulatory tracker: Amgen's bispecific approved for small cell lung cancer in UK
Welcome to Fierce Pharma's regulatory tracker for the first half of 2025. | In this tracker, Fierce Pharma is recording the ...
FiercePharma
3 天
Novo asks FDA to restrict Victoza compounding amid GLP-1 outsourcing row
In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies ...
FiercePharma
3 天
BioNTech inks settlements with NIH, Penn in COVID-19 vaccine royalty disputes
The German drugmaker will pay the NIH $791.5 million, while the University of Pennsylvania will get up to $467 million ...
FiercePharma
3 天
Roche projected to claim pharma's 2025 sales crown as Novo, Lilly climb rankings: Evaluate
The story of Eli Lilly and Novo Nordisk’s GLP-1 dominance is likely to play out again in 2025 as the metabolic medicine ...
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