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Lilly Opposes Tirzepatide Bulks List Nomination

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Lilly calls on FDA to reject the Outsourcing Facilities Association nomination of tirzepatide to be on the 503 Bulks List so it ca...

Clinical Hold on Novavax Vaccines Lifted

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FDA removes a clinical hold on a Novavax IND for its Covid-19-influenza combination and stand-alone flu vaccine candidates.

Autolus Wins OK for Leukemia CAR-T Theray

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FDA approves an Autolus Therapeutics BLA for Aucatzyl (obecabtagene autoleucel), a CAR-T therapy for treating adult patients with ...

Safety Issue Prompts Zelnecirnon Termination

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Rapt Therapeutics terminates its zelnecirnon drug development program due to a serious liver safety issue.

J&Js Nipocalimab Gets Breakthrough Status

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FDA grants Johnson & Johnson a breakthrough therapy designation for nipocalimab and its use for treating Sjgren's disease.

Disappointing Data in Schizophrenia Drug: AbbVie

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AbbVie says its two Phase 2 EMPOWER trials investigating emraclidine as a once-daily, oral monotherapy treatment for adults with s...

Brookfield Medical Hit with GMP Untitled Letter

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FDA posts an untitled letter sent to Brookfield Medical/Surgical Supplies due to GMP issues cited in a May inspection.

Unicycive Therapeutics NDA for Oxylanthanum

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FDA accepts for review a Unicycive Therapeutics 505 (b) (2) NDA for oxylanthanum carbonate and its use in treating hyperphosphatem...

FDA Clears Vertiwedge Intraosseous Device

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FDA clears a Foundation Surgical 510(k) for its Vertiwedge Intraosseous, a motion-sparing partial vertebral body replacement devic...

Group Criticizes FDA Foot Dragging on Phenylephrine

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Advocacy group Public Citizen criticizes FDA for dragging its feet in removing phenylephrine from the U.S. market.