drug safety – Talk Bio

FDA Begins Daily Publication of Drug Adverse Event Data

2 weeks ago talkbio0Tagged Adverse event, Daily, data modernization, drug safety, FAERS, public health medicine (field), real-time monitoring, United States Food and Drug Administration

FDA; FAERS; adverse event reporting; daily publishing; data modernization; drug safety; real-time monitoring; public health

Schrödinger Halts SGR-2921 Leukaemia Programme After Two Deaths

4 weeks ago talkbio0Tagged CDC7 protein, human, clinical trial halt, drug safety, Inhibitor, leukemia, Leukemia, Myelocytic, Acute, MYELODYSPLASTIC SYNDROME, patient deaths, Schrödinger, SGR-2921

Schrödinger; SGR-2921; leukaemia; acute myeloid leukaemia (AML); myelodysplastic syndromes (MDS); CDC7 inhibitor; clinical trial halt; patient deaths; drug safety

Avalyn Pharma Raises $100M to Advance Inhaled Lung Disease Drugs

2 months ago talkbio0Tagged AP01, AP02, aspects of adverse effects, Avalyn, Clinical Trials, drug safety, Holdings, inhaled lung disease, nintedanib, Pharma, pirfenidone, Pulmonary Fibrosis, Series D, SNCG gene, Suvretta Capital Management

Avalyn Pharma; $100 million Series D; inhaled lung disease medications; pulmonary fibrosis; AP01; AP02; pirfenidone; nintedanib; clinical trials; drug safety; side effects; Suvretta Capital Management; SR One; Novo Holdings

Sarepta Stands Ground Against HHS Request To Stop Elevidys Shipments

2 months ago talkbio0Tagged AAVrh74, CHARGE Syndrome, drug safety, ELEVIDYS, gene therapy, Muscular Dystrophy, Duchenne, patient deaths, Regulatory Action, Ships, Suspensions, United States Food and Drug Administration

Sarepta; Elevidys; FDA; HHS; gene therapy; Duchenne muscular dystrophy; drug safety; shipping suspension; patient deaths; AAVrh74; regulatory action

FDA Advisory Committee Votes Against GSK’s Blenrep in Multiple Myeloma

2 months ago talkbio0Tagged Advisory Committees, Clinical Trials, drug safety, Eye, Multiple Myeloma, ODAC, SmithKline Beecham, Toxicity aspects, United States Food and Drug Administration, vote

FDA Advisory Committee; Blenrep; GSK; multiple myeloma; ODAC vote; drug safety; ocular toxicity; clinical trials

Mayne Pharma Faces FDA Action Over ‘Misleading’ Drug Safety Claims Ahead of $430M Buyout

4 months ago talkbio0Tagged Claims, Contraceptives, Oral, Cosette Pharmaceuticals, drug safety, Mayne, Nextstellis, Pharma, United States Food and Drug Administration

Mayne Pharma; FDA; misleading claims; Nextstellis; birth control pill; drug safety; buyout; Cosette Pharmaceuticals

Former FDA Officials Sound Alarm: Visible Changes May Be Tip of the Iceberg

5 months ago talkbio0Tagged Alarm device, Changing, Disease Outbreaks, drug safety, Icebergs, KAT5 wt Allele, Leadership, Policy, Previous, public health medicine (field), United States Food and Drug Administration, Vaccines, Visible

United States Food and Drug Administration, public health medicine (field), Changing, Vaccines, Leadership, Policy, drug safety, Previous, KAT5 wt Allele, Icebergs, Disease Outbreaks, Alarm device, Visible

EU PFAS Ban Threatens Pharmaceutical Packaging Industry: Challenges and Implications

7 months ago talkbio0Tagged chain disruption, chemical alternatives, drug safety, environmental, EU, PFAS gene, Pharmaceutical Packaging, regulatory

PFAS ban, pharmaceutical packaging, EU regulations, supply chain disruption, chemical alternatives, environmental protection, drug safety