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FDA Removes Use Limitation for Yescarta in Rare Lymphoma

[ Price : $8.95]

FDA approves a Kite Oncology labeling update for CAR-T therapy Yescarta (axicabtagene ciloleucel), removing a previous limitation ...

Makary Warns Illegal Copycat Drugs Will Face Swift Enforcement

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FDA pledges to move quickly against companies that mass-market illegal copycat drugs by portraying them as equivalent to agency-ap...

Breakthrough Status for Sonorous BosSTENT for Pulsatile Tinnitus

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FDA grants Sonorous Neurovascular a breakthrough device designation for its BosSTENT, a cerebral venous stent designed to treat de...

Trust in FDA and CDC Remains Low After Vaccine Changes

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A new poll finds public confidence in FDA and Centers for Disease Control and Prevention remains low following recent changes to t...

FDA Flags Manufacturing/Quality Lapses at Ipcas India API Plant

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FDA cites Ipca Laboratories over multiple manufacturing and quality deficiencies following an inspection of the companys active ph...

ICH Patient Preference Guidelines Out for Comment

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FDA publishes for public comment an International Council for Harmonization draft guideline on patient preference studies involvin...

Sangamo Begins Rolling BLA for Fabry Gene Therapy

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Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, ...

Bayers Asundexian Cuts Recurrent Stroke Risk in Phase 3

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Bayer reports that its investigational oral anticoagulant asundexian reduced the risk of recurrent ischemic stroke by 26% in patie...

Industry Explains PDUFA 8 Facility Lifecycle Counterproposal

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A PDUFA 8 negotiating subgroup reviews industrys counterproposal to FDAs facility lifecycle proposal.

Telehealth Firm Undercuts Novo GLP-1 Pill Price: Reuters

[ Price : $8.95]

Reuters reports exclusively that the telehealth firm Hims and Hers Health is selling GLP-1 pills for $100 less per month than the ...