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PhRMA Comments on FDA Safety Reporting Guide

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PhRMA tells FDA it appreciates many of the revisions the agency has made to a draft guidance on sponsor responsibilities for safet...

Priority Review for ViiVs Cabotegravir HIV Preventer

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FDA grants priority review to ViiVs cabotegravir to prevent acquisition of HIV in certain men.

Affordable Healthcare Pleads Guilty in Adulterated Device Case

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The Justice Department says Affordable Healthcare Solutions pled guilty to one felony count of receiving adulterated medical devic...

Regeneron Libtayo sBLA for Cervical Cancer

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FDA accepts for review a Regeneron Pharmaceuticals supplemental BLA for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat certain ...

Eisai Rolling BLA for Alzheimers Drug

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Eisai begins a rolling BLA submission for lecanemab, the companys investigational anti-amyloid beta protofibril antibody for treat...

Pfizer Amends Trial Protocol Due to Adverse Events

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Pfizer submits a clinical trial protocol amendment for a Phase 3 gene therapy trial for fordadistrogene movaparvovec in Duchenne M...

Workshop on Analgesic Clinical Trial Designs

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Federal Register notice: FDA announces a 10/13-14 public workshop entitled Analgesic Clinical Trial Designs, Extrapolation, and En...

Lilly Recalls 1 Lot of Glucagon Emergency Kit

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Eli Lilly recalls one lot of its Glucagon Emergency Kit for Low Blood Sugar after receiving a product complaint reporting that a v...

BMS Files 2 sBLAs for Opdivo/Yervoy

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FDA accepts for review two Bristol Myers Squibb supplemental BLAs for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) a...

FDA and UK Expand Mutual Recognition Agreement

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FDA and the United Kingdom expand their ongoing mutual recognition agreement to include animal drug inspections.