Cautionary Warning

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

1 month ago talkbio0Tagged Cautionary Warning, Incheon, Janssen Vaccines, Johnson & Johnson, Korean language, pharmaceutical manufacturing, Plants, production, quality control violations, spotty complaint reporting, United States Food and Drug Administration, vial stopper defects

FDA warning letter; Johnson & Johnson subsidiary; Janssen Vaccines; Korean production plant; vial stopper defects; quality control violations; spotty complaint reporting; good manufacturing practices; Incheon; pharmaceutical manufacturing

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

1 month ago talkbio0Tagged Burning Mouth Syndrome, Cautionary Warning, Correspondence as Topic, Crackdown, Direct-to-Consumer, drug marketing compliance, Eli Lilly, Novartis, Pfizer, pharma TV ads, provision, Sufficient, United States Food and Drug Administration

FDA crackdown; pharma TV ads; Pfizer; Novartis; BMS; Lilly; warning letters; direct-to-consumer advertising; adequate provision rule; drug marketing compliance

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

1 month ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

FDA restricts bluebird bio’s Skysona to CALD patients without suitable stem cell donors after higher blood cancer risk emerges

3 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Donor person, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA Match, label update, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; eli-cel; cerebral adrenoleukodystrophy; CALD; hematologic malignancies; myelodysplastic syndrome (MDS); acute myeloid leukemia (AML); boxed warning; label update; postmarketing safety; HLA-matched donor; gene therapy safety

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

3 months ago talkbio0Tagged boxed, CALD, Cautionary Warning, Cerebral Adrenoleukodystrophy, Elivaldogene autotemcel, gene therapy, Hematologic Neoplasms, HLA‑matched donor, labeling changes, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, Safety, Skysona, United States Food and Drug Administration

FDA; bluebird bio; Skysona; elivaldogene autotemcel; labeling changes; boxed warning; hematologic malignancy; myelodysplastic syndrome; acute myeloid leukemia; cerebral adrenoleukodystrophy; CALD; HLA‑matched donor; gene therapy safety; post‑marketing reports

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

3 months ago talkbio0Tagged Cautionary Warning, Chief, Does speak, Drug Industry, drug price, Eli Lilly, International Drug Prices, MFN, Policy, U.S.

Lilly chief; MFN talks; international drug prices; US drug pricing; pharmaceutical industry; policy warning

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

3 months ago talkbio0Tagged acute liver injury, black box, Cautionary Warning, ELEVIDYS, gene therapy, layoffs, Muscular Dystrophy, Duchenne, pipeline shift, restructuring, RNA, Small Interfering

Sarepta Therapeutics; siRNA platform; Elevidys; Duchenne muscular dystrophy; layoffs; black box warning; pipeline shift; acute liver injury; gene therapy; restructuring

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

5 months ago talkbio0Tagged Aldose Reductase Inhibitor, Apply, Cautionary Warning, Classical galactosemia, clinical trial conduct, Govorestat, Infrequent, Rejection, United States Food and Drug Administration

Applied Therapeutics; govorestat; rare disease; phase 3 failure; FDA rejection; classic galactosemia; aldose reductase inhibitor; clinical trial conduct; FDA warning letter