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Autism Warning Marks Sharp Break from Standards: Attorneys

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Attorneys from Mintz warn that FDAs recent safety communication on acetaminophen and autism may signal a departure from long-stand...

FDA Grants Priority Review to J&Js Akeega sNDA

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FDA accepts for priority review a Johnson & Johnson supplemental NDA for Akeega (niraparib and abiraterone acetate dual-action tab...

Novartis Fabhalta Slows Kidney Function Decline

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Novartis reports that a Phase 3 trial of its oral complement inhibitor Fabhalta (iptacopan) showed the therapy slowed kidney funct...

Create Drug Facts Box for DTC Ads: Column

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Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers can understand a drugs benefi...

Positive Results for Tecvayli/Darzalex Faspro Combo

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Johnson & Johnson says an independent data monitoring committee recommended unblinding the MajesTEC-3 study of Tecvayli and Darzal...

AI, RWE in FDA Decisions

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Hyman, Phelps & McNamara principal medical device regulation expert Adrienne Lenz says FDA is preparing for a future where artific...

FDA Urges High Court Rejection of Vanda Petition

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FDA urges the Supreme Court to reject Vanda Pharmaceuticals petition challenging the agencys decision to deny fast-track status fo...

3 Observations from Lupin Pithampur Inspection

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FDA releases the form FDA-483 with three observations from its inspection at the Lupin drug manufacturing facility in Pithampur, M...

Orphan Status for Minovia Myelodysplastic Drug

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Minovia Therapeutics wins an FDA orphan drug designation for its lead investigational therapy, MNV-201, for myelodysplastic syndro...

FDA Accepts Chiesis Triple Combination Asthma Inhaler

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FDA accepts for review a Chiesi NDA for a single-inhaler triple therapy designed for the maintenance treatment of asthma in adults...