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Janssen Gets Expanded Label for HIV-treating Cabenuva

[ Price : $8.95]

FDA approves a Janssen Pharmaceutical expanded label for Cabenuva (rilpivirine and cabotegravir) to be administered every two mont...

Clinical Hold on LogicBio Gene Therapy

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FDA orders a clinical hold on LogicBio Therapeutics Phase 1/2 SUNRISE clinical trial involving LB-001 in pediatric patients with m...

FDA Names House Staffer Associate Commissioner

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FDA names House Energy and Commerce Committee chief health advisor Kimberlee Trzeciak as the agencys associate commissioner for le...

Bone Solutions 510(k) Cleared for Mg Osteorevive

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FDA clears a Bone Solutions 510(k) for its Mg Osteorevive, a magnesium-based injectable and moldable bone void filler indicated fo...

Jazz Pharma sBLA for M/W/F Rylaze Dosing

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Jazz Pharmaceuticals submits a supplemental BLA for a Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze (asparagina...

Pfizer Seeking Vaccine EUA for Tots: Reports

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Bloomberg News reports that Pfizer/BioNTech are submitting rolling data for an EUA for Covid-19 vaccinations for kids between six ...

Firm Selling Misbranded, Unapproved Drugs: FDA

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FDA warns Scottsdale, AZ-based Applied Health Solutions that it is marketing unapproved and misbranded new drugs on its Web site.

Benefits of Decentralized Clinical Trials Cited

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A Tufts Center for the Study of Drug Development analysis shows the financial and other benefits of decentralized clinical trials.

2021 Drug Safety Priorities Report

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FDA issues the 2021 drug safety priorities report, the seventh in a series highlighting CDER and FDA drug safety activities.