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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...

Congress Clarifies Orphan Drug Exclusivity & Generic Transparency

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A new spending package enacted this week includes two long-sought policy changes for FDA clarifying the scope of orphan drug excl...

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

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

J&Js Cerenovus Recalls Neurovascular Coil Devices

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Johnson & Johnson MedTech recalls multiple versions of its Cerepak Detachable Coil System, which are used to treat intracranial an...

U.S. Specialty Formulations FDA-483 Out

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FDA releases the form FDA-483 with seven observations from an inspection at the U.S. Specialty Formulations outsourcing facility i...