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Diversity Action Plan Submissions Up

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FDA says voluntary submission of clinical study diversity action plans increased from FY 2023 to FY 2024.

XO Biologix Marketing Unapproved, Adulterated Drug

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FDA warns Austin, TX-based XO Biologix that it is marketing an unapproved adulterated and misbranded product derived from amniotic...

FDA Fast Track for J&J Alzheimers Drug

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FDA grants fast-track designation to posdinemab, an investigational J&J Alzheimers drug.

1st Cycle NDA Approvals Fall in 2024: CDER

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A CDER drug approval reports shows that first-cycle NDA approvals fell in 2024 to 74% (37 of the 50 novel drugs approved) from 84%...

FDA Sees Challenges in Condoliase BLA

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FDA asks members of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss several challenges the agency has ide...

Vanda Criticizes FDA Over Drug Rejection

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Vanda Pharmaceuticals criticizes FDA for failing to approve the companys NDA for tradipitant to treat the symptoms of gastroparesi...

5 Repeat CGMP Violations at Indoco Remedies

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FDA warns Indias Indoco Remedies about repeat CGMP violations in its production of finished drugs.

FDA Obesity/Overweight Drug Development Guide

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FDA publishes a draft guidance with recommendations on clinical trials for drugs and biologics to treat obesity and overweight.

Off-Label Communications Q&A Guide

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FDA issues a guidance finalizing a 2023 draft document on communicating scientific information on unapproved uses of approved or c...

Rybrevant/Lazcluze Cancer Study Positive: J&J

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Johnson & Johnson says its Phase 3 MARIPOSA study showed that its Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) had a st...