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Follow Laws Intent on Drug Innovation: Scott, Carter

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Sen. Tim Scott and Rep. Earl Carter say a recent FDA guidance on advanced manufacturing technologies for drugs does not match cong...

Genetic Metabolic Diseases Panel Established

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Federal Register notice: FDA amends its standing advisory committee regulations to add the 12/13/2023 establishment of the Genetic...

Zevra Therapeutics NDA Review Extended

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FDA extends by three months its review on a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment...

FDA OKs Hugels Frown Lines Neurotoxin

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FDA approves Hugels Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults.

Panel to Meet on Next Covid Vaccine Makeup

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Federal Register notice: FDA announces a 5/16 Vaccines and Related Biological Products Advisory Committee meeting to discuss the s...

Hold Lifted on Iovance Lung Cancer Trial

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FDA removes a partial clinical hold on Iovance Biotherapeutics IOV-LUN-202 trial investigating the companys LN-145 TIL cell therap...

SpringWorks Rolling NDA for Mirdametinib

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SpringWorks Therapeutics commences a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adu...

Oregon Medical Cited Over Social Media Claims

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CBER cites Oregon Medical Centers in an untitled letter over claims it is making on social media sites Facebook and Youtube about ...

Boston Scientific PMA OKd for Stent

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FDA approves a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis ...

Fresh Allograft Heart Valves Regulated by FDA

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FDA affirms its regulation of fresh allograft heart valves in a just-posted letter to healthcare professionals.