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FDA Clears Cresilons Traumagel

[ Price : $8.95]

FDA clears Cresilons Traumagel device that uses a plant-based technology to control moderate to severe bleeding at the point of ca...

FDA Touts CDER Advanced Manufacturing Research Facility

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FDA describes CDERs new state-of-the-art advanced manufacturing research facility.

Priority Review for Imfinzi sBLA in Lung Cancer

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FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in certain patients with limi...

Rare Disease Status Given to Duchenne Therapy

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FDA grants Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscula...

NexoBrid Gets Expanded Use for Pediatric Burns

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FDA approves a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-...

Stakeholders Comment on Advisory Committee Session

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Two stakeholders respond to an FDA request for comments on the agencys recent listening session on advisory committees and their g...

FDA Pushed to Regulate Online Drug Promos

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Gardner Law says prescription drug manufacturers and marketers need to be sure their social media promotions can withstand FDA scr...

Accelerated Approval for Gileads Livdelzi

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FDA gives accelerated approval to Gileads Livdelzi to treat some cases of primary biliary cholangitis.

Verrica Positive Data from Skin Cancer Trial

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After reporting preliminary positive results from a Phase 2 clinical trial studying VP-315 in basal cell carcinoma patients, Verri...

FDA Approves Incytes Niktimvo

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FDA approves Incytes Niktimvo for some adult and pediatric host-versus-graft treatments.