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Sen. Durbin Calls for Crackdown on DTC Telehealth

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Senator Dick Durbin (D-IL) calls for a crackdown on pharmaceutical companies growing use of direct-to-consumer telehealth platform...

ICH Guide on Including Pregnant Women in Trials

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FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women i...

FDA Rejects Genentechs Bid to Expand Columvi Use

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FDA rejects Genentechs bid to broaden the use of its lymphoma drug Columvi.

Panel Votes Down Rexulti for PTSD

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FDAs Psychopharmacologic Drugs Advisory Committee votes against approving an Otsuka Pharma NDA for Rexulti (brexpiprazole) when us...

FDA Mulls Pulling Sareptas Gene Therapy

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An HHS official says FDA is taking a hard look at pulling from the market Sarepta Therapeutics gene therapy Elevidys (deland...

FDA AI Moves Raise Questions: Attorneys

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Three Akin attorneys say regulated industry continues to have questions about FDA actions in launching an internal artificial inte...

Panel Votes Down GSK Multiple Myeloma Drug

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FDAs Oncologic Drugs Advisory Committee votes against approving GSKs BLA for Blenrep (belantamab mafodotin) for treating adults wi...

Dexcom Recalls Dexcom Glucose Monitor Receivers

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Dexcom recalls certain Dexcom G6, G7, ONE, and ONE+ glucose monitoring receivers because a speaker problem may prevent an alert fr...

Investigate GLP-1 Online Marketing: Blackburn

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Sen. Marsha Blackburn and Tennessee attorney general Jonathan Skrmetti call on the Federal Trade Commission to open an investigati...

CDER Losing Staff In Droves: Report

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An online post details a significant number of resignations from CDER in the first six months of this year.