Posts

USFDA Issues Warning Letter to Alembic Clinical Investigator Over Informed Consent Form Issues

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Novo Nordisk and Alvotech Face Continued FDA Scrutiny at Plants Tied to Recent FDA Rejections

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FDA drops blood pressure device enforcement against Whoop

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Medline Faces FDA Warning Over Repeat *Bacillus cereus* Contamination in Drug Products

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Takeda Restructuring: Over 600 US Layoffs Amid $1.3B Transformation Plan

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ImmunityBio Responds to FDA Warning on Anktiva Promotional Claims with New Protocols

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ImmunityBio Faces FDA Warning Letter Over Anktiva Promotions in TV Ad and Podcast Episode

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Kennedy’s Vaccine Agenda Stalled by Court, Structure’s Obesity Pill Advances, Novo Nordisk Faces FDA Warning

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Hims & Hers Faces Escalating FDA Scrutiny Over Compounding Pharmacy Violations and Semaglutide Products

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FDA Commissioner Makary Addresses COVID-19 Vaccine Safety Concerns Amid Internal Debates and Investigations

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Merck Continues Cuts: 204 Employees Laid Off in New Jersey

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FDA Issues Warning Letter to J&J Subsidiary Over Stopper Issues and Quality Reporting at Korean Plant

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FDA Crackdown on Pharma TV Ads Targets Pfizer, Novartis, BMS, Lilly & Others

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Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

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FDA tightens Skysona label, restricting use to CALD patients without alternative options due to increased blood cancer risk

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Amid MFN Talks, Lilly Chief Warns US Adoption of International Drug Prices Could Bring ‘Worst of Two Worlds’

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Sarepta Shifts Focus to siRNA Platform, Lays Off 500 After Elevidys Receives Black Box Warning

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Applied Therapeutics' Rare Disease Drug Fails Another Phase 3 Trial After FDA Rejection

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