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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.

Workshop on Measuring Gonadal Toxicity

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FDA and the American Society of Clinical Oncology announce a 10/1 joint workshop entitled Measuring Toxicity in Reproductive Organ...