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Gaps Seen in Dementia AI Device Transparency

[ Price : $8.95]

Researchers call for greater transparency of artificial intelligence/machine learning training and validation datasets in devices ...

FDA OKs Ionis Hereditary Angioedema Drug

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FDA approves an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for heredit...

Rinvoq Meets Endpoints in Alopecia Trial

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AbbVie reports that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing...

21% of FDA Staff Gone: Analysis

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An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten...

14 States Join Mifepristone Petition to FDA

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14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their s...

FDA Orphan Status for Keros Duchenne Candidate

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FDA grants Keros Therapeutics an orphan drug designation for its investigational therapy KER-065 and its use in treating Duchenne ...

Workshop on Allergic Dermatitis Patch Test Alternatives

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FDA announces a 10/23 public workshop to discuss the regulatory status of, and potential alternatives to, patch tests used in diag...

Nucleus RadioPharma Names Former FDA Head as CEO

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Nucleus RadioPharma appoints former FDA commissioner Stephen Hahn (Trump Administration 2019-2021) as its chief executive officer.

FDA Rejects enVVeno Medical Venous Valve PMA

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FDA issues enVVeno Medical a not-approvable letter for its PMA on VenoValve, a surgical replacement venous valve designed to treat...

FDA Lifts Hold on Rockets Gene Therapy

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FDA lifts a clinical hold on Rocket Pharmaceuticals pivotal Phase 2 trial of RP-A501, an investigational gene therapy for Danon di...