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Roche Reports Mixed Data on COPD Studies

[ Price : $8.95]

Roche reports mixed data on its investigational chronic obstructive pulmonary disease drug astegolimab in two key late-stage clini...

Maquet Servo Ventilators in Class 1 Recall

[ Price : $8.95]

Maquet Critical Care recalls (Class 1) its Servo Ventilator Systems to update their use instructions due to the risk of inaccurate...

J&J Seeks Approval for Oral Peptide for Psoriasis

[ Price : $8.95]

Johnson & Johnson files an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque ...

FDA Mulls Pulling Sareptas Gene Therapy

[ Price : $8.95]

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

Guide on Biosimilar Formal Meeting Requsts

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FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

SunMed Manual Resuscitators Recalled

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SunMed Holdings recalls its Adult Manual Resuscitator devices due to incorrect assembly of the bacterial/viral filter.

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FDA posts an International Conference on Harmonization draft guidance entitled E21 Inclusion of Pregnant and Breastfeeding Women i...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