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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...

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 ...

Darxalex Faspro sBLA for Smoldering Multiple Myeloma

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Johnson & Johnson files a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) and its use for treating adult...

Bayers Medrad Centargo CT Injection Cleared

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FDA clears a Bayer 510(k) for its Medrad Centargo CT Injection System, a multi-patient injector for use in computed tomography.

Allogene Reports Encouraging CAR-T Therapy Data

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Allogene Therapeutics reports encouraging response rate data for its investigational ALLO-316 in advanced renal cell carcinoma, bu...

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.