United States Food and Drug Administration – Page 2

FDA Drug Approvals in 2025 Remain Within Recent Averages Amid Agency Upheaval

6 days ago talkbio0Tagged 2025, CBER, CDER, Drug Approval, molecular entities, trends qualifier, United States Food and Drug Administration

FDA; drug approvals; 2025; new molecular entities; CDER; CBER; trends; novel drugs

Regeneron Heads to FDA Seeking Approval for Game-Changing Hearing Loss Gene Therapy

6 days ago talkbio0Tagged Approved, CHORD trial, DB-OTO, Deafness, gene therapy, OTOF gene, Regeneron, United States Food and Drug Administration

Regeneron; hearing loss; gene therapy; DB-OTO; FDA approval; OTOF gene; CHORD trial

Satellos Advances Duchenne Pill Trial in Children; Idorsia Raises $81 Million

7 days ago talkbio0Tagged Child, Fund Raising, Idorsia, Indonesian language, Muscular Dystrophy, Duchenne, oral small-molecule therapy, Phase 2 clinical trial, SAT-3247, Satellos, Submission, United States Food and Drug Administration

Satellos; Duchenne muscular dystrophy; SAT-3247; Phase 2 clinical trial; children; FDA IND submission; oral small-molecule therapy; Idorsia; fundraising; biotech

Xspray’s Dasynoc Faces FDA Approval Delay Due to Contract Manufacturing Issues

1 week ago talkbio0Tagged Acute lymphocytic leukemia, Complete Response Letter, contract manufacturer, Dasynoc, Drug Approval Process, manufacturing issues, manufacturing practice, Myeloid Leukemia, Chronic, United States Food and Drug Administration, Xspray Pharma

Dasynoc; Xspray Pharma; FDA; Complete Response Letter; manufacturing issues; good manufacturing practice; contract manufacturer; chronic myeloid leukemia; acute lymphoblastic leukemia; drug approval process

AI is Transforming Drug Safety—But Governance Sets Essential Guardrails

1 week ago talkbio0Tagged Adverse reaction to drug, AI guardrails, Artificial Intelligence, Bias (Epidemiology), Data Integrity, drug safety, Jeavons syndrome, patient safety, Pharmacovigilance, regulatory governance, United States Food and Drug Administration

artificial intelligence; drug safety; pharmacovigilance; adverse drug events; regulatory governance; FDA; EMEA; AI guardrails; data integrity; bias; patient safety

Boehringer Ingelheim Breaks Decade-Long Drought with FDA Approval of Jascayd for Idiopathic Pulmonary Fibrosis

1 week ago talkbio0Tagged Approved, Boehringer Ingelheim, Chronic lung disease, Idiopathic Pulmonary Fibrosis, Jascayd, lung scarring, nerandomilast, Pulmonary Fibrosis, United States Food and Drug Administration

Boehringer Ingelheim; Jascayd; nerandomilast; FDA approval; idiopathic pulmonary fibrosis; IPF; lung scarring; first new treatment; chronic lung disease

FDA Launches Pilot Program to Prioritize U.S. Generic Drug Manufacturing and Testing

2 weeks ago talkbio0Tagged ANDA, bioequivalence testing, domestic manufacturing, Drug Approval, Pharmaceutical Supply Chain, pilot program, Prioritization, resilience, supply chain, United States, United States Food and Drug Administration

FDA; pilot program; generic drugs; ANDA prioritization; domestic manufacturing; bioequivalence testing; U.S. pharmaceutical supply chain; drug approval; supply chain resilience

Rocket Pharmaceuticals Withdraws FDA Application for Rare Blood Disease Gene Therapy

2 weeks ago talkbio0Tagged Fanconi Anemia, gene therapy, Mozafancogene Autotemcel, pipeline pivot, Rocket Pharmaceuticals, United States Food and Drug Administration

Rocket Pharmaceuticals; FDA; RP-L102; Fanconi Anemia; Gene Therapy; Pipeline Pivot

Recent Advances Shifting Perspectives in Cell Therapy (2025)

2 weeks ago talkbio0Tagged CAR T-cell, Cell Therapy, Clinical Trials, controllable, CRISPR therapies, immune cells, Labels (device), Mesenchymal Stem Cells, patient-specific therapy, Solid Neoplasm, United States Food and Drug Administration, Updates

cell therapy; CAR T-cell; solid tumors; FDA label updates; mesenchymal stem cells; CRISPR therapies; patient-specific therapy; ultrasound controllable immune cells; clinical trials

Legal Pressure Escalates as FDA Intensifies Crackdown on Direct-to-Consumer Pharma Advertising

2 weeks ago talkbio0Tagged Advertising (activity), CHARGE Syndrome, Compound, Direct-to-Consumer Advertising, enforcement, Legal Challenges, pharmaceutical advertising crackdown, Pharmacy facility, prescription drug ads, Preventive monitoring, United States Food and Drug Administration, warning letters

FDA enforcement; direct-to-consumer advertising; pharmaceutical advertising crackdown; warning letters; legal challenges; AI monitoring; prescription drug ads; transparency in advertising; HHS; compounding pharmacies