United States Food and Drug Administration – Page 6

Regeneron Prepares U.S. Submission for Garetosmab After Breakthrough Phase III Result in Ultra-Rare FOP

1 month ago talkbio0Tagged bone lesion prevention, Drugs, Orphan, fibrodysplasia, Fibrodysplasia Ossificans Progressiva, Garetosmab, Infrequent, OPTIMA trial, ossificans, Phase III, progressiva, Regeneron, Submission, United States Food and Drug Administration

Regeneron; garetosmab; FOP; fibrodysplasia ossificans progressiva; Phase III; OPTIMA trial; bone lesion prevention; rare disease; FDA submission; orphan drug

FDA Scrutinizes Telehealth Firms Like Hims for GLP-1 Drug Advertising Practices

1 month ago talkbio0Tagged Drug Compounding, Glucagon-Like Peptide 1, Hims, Super Bowl ad, Telemedicine, United States Food and Drug Administration, Weight-Loss Agents

FDA; Hims; telehealth; GLP-1; advertising; weight-loss drugs; compound drugs; Super Bowl ad; misleading claims

FDA Cracks Down on Misleading Drug Ads in Major Pharmaceutical Companies

1 month ago talkbio0Tagged Crackdown, Misleading Drug Ads, pharmaceutical companies, United States Food and Drug Administration

FDA; Misleading Drug Ads; Pharmaceutical Companies; Crackdown

Next-Generation Psoriasis Drugs Aim to Reshape Treatment Landscape

1 month ago talkbio0Tagged Approved, Clinical Trials, icotrokinra, inhibitors, interleukin-23, next-generation biologics, oral peptides, Piclidenoson, TYK2 gene, United States Food and Drug Administration, Vunakizumab

psoriasis; next-generation biologics; icotrokinra; IL-23 inhibitors; oral peptides; TYK2 inhibitors; vunakizumab; piclidenoson; clinical trials; FDA approval

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

CSL Commits $117M for Option to Acquire VarmX and Advance Novel Blood Clotting Therapy to Market

1 month ago talkbio0Tagged Acquisition, Anticoagulants, antithrombin III, blood clotting drug, critical bleeding, Partnership, SMPX gene, United States Food and Drug Administration, VarmX, VMX-C001

CSL; VarmX; VMX-C001; blood clotting drug; Factor Xa inhibitors; anticoagulants; Phase 3 clinical trial; acquisition; biotech partnership; critical bleeding; FDA fast-track

FDA Targets Misleading Drug Ads, Shifting Strategy Could Make Ads Less Feasible

1 month ago talkbio0Tagged drug ads, Makary, Marty, Regulatory Crackdown, United States Food and Drug Administration

FDA; Marty Makary; Drug Ads; Regulatory Crackdown

Capsida Suspends Gene Therapy Trial After First Patient Death

1 month ago talkbio0Tagged CAP-002, Capsida Biotherapeutics, Clinical Trial Suspension, Encephalopathies, gene therapy, Patient Death, STXBP1 gene, United States Food and Drug Administration

Capsida Biotherapeutics; gene therapy; CAP-002; clinical trial suspension; STXBP1 encephalopathy; patient death; FDA

FibroGen Settles with SEC for $1.25M Over Roxadustat Data Tampering Allegations

1 month ago talkbio0Tagged Anemia, cardiovascular safety, Clinical Trials, data manipulation, FibroGen, Kin-Hung Peony Yu, Phase 3, roxadustat, seconds, settlement, United States Food and Drug Administration

FibroGen; SEC; roxadustat; data manipulation; settlement; Kin-Hung Peony Yu; phase 3 clinical trial; anemia drug; cardiovascular safety; FDA

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

1 month ago talkbio0Tagged Clinical Trials, concerns, Drug withdrawal syndrome, Injury of liver, Intercept Pharmaceuticals, Liver diseases, Ocaliva, Primary Biliary Cholangitis, regulatory setbacks, Safety, United States Food and Drug Administration

Intercept Pharmaceuticals; Ocaliva; liver disease; primary biliary cholangitis; FDA; drug withdrawal; safety concerns; liver injury; clinical trial hold; regulatory setbacks