United States Food and Drug Administration – Page 18

FDA Approves UNLOXCYT for Advanced Cutaneous Squamous Cell Carcinoma, Marking a New Era in Skin Cancer Treatment

4 months ago talkbio0Tagged Approved, checkpoint inhibitor, cosibelimab-ipdl, Immunotherapy, Malignant neoplasm of skin, Squamous cell carcinoma, Squamous cell carcinoma of skin, United States Food and Drug Administration, UNLOXCYT

UNLOXCYT, cosibelimab-ipdl, FDA approval, advanced cutaneous squamous cell carcinoma (cSCC), checkpoint inhibitor, immunotherapy, skin cancer treatment.

FDA Halts Pediatric RSV Vaccine Trials Due to Safety Concerns

5 months ago talkbio0Tagged concerns, pediatric trials, Respiratory syncytial virus, Risk, Safety, United States Food and Drug Administration, Vaccines, VAERD

RSV vaccines, pediatric trials, safety concerns, FDA hold, VAERD risk

FDA Warns of Serious Liver Injury Risk with Ocaliva (Obeticholic Acid) in Patients with Primary Biliary Cholangitis

5 months ago talkbio0Tagged Biliary Cholangitis, Cautionary Warning, Injury of liver, Liver diseases, medication safety, obeticholic acid, Ocaliva, United States Food and Drug Administration

Ocaliva, obeticholic acid, liver injury, FDA warning, primary biliary cholangitis, liver disease, medication safety

Biotech Industry Prepares for Trump 2.0: Regulatory Changes and M&A Activity Expected

5 months ago talkbio0Tagged biotech industry, Changing, Drug Industry, Health Policy, M&A activity, regulatory environment, Transplant Registry Unified Management Program, United States Food and Drug Administration

Biotech industry, Trump 2.0, FDA changes, M&A activity, regulatory environment, pharmaceutical industry, healthcare policy

Ocaliva (Obeticholic Acid) Linked to Increased Risk of Liver Failure in PBC Patients Without Cirrhosis

5 months ago talkbio0Tagged Cautionary Warning, Injury of liver, Liver Cirrhosis, Liver Failure, obeticholic acid, Ocaliva, Primary Biliary Cholangitis, United States Food and Drug Administration

Ocaliva, obeticholic acid, primary biliary cholangitis (PBC), liver failure, liver injury, cirrhosis, FDA warning.

Candel Therapeutics Sees Dramatic Stock Surge Following Successful Phase III Prostate Cancer Trial

5 months ago talkbio0Tagged Approved, CAN-2409, Candel, Malignant neoplasm of prostate, Phase 3 Clinical Trials, surge, United States Food and Drug Administration, viral immunotherapy

Candel Therapeutics, CAN-2409, Phase III trial, prostate cancer, viral immunotherapy, stock surge, FDA approval

Moderna’s RSV Vaccines Face Safety Concerns Over Severe Infections in Infants

5 months ago talkbio0Tagged Advisory Committees, concerns, Infant, Moderna, Respiratory syncytial virus, RNA, Messenger, Safety, United States Food and Drug Administration, Vaccines

Moderna, RSV vaccines, safety concerns, severe infections, infants, mRNA vaccines, FDA, advisory committee

uniQure Secures FDA Agreement on Accelerated Approval Pathway for Huntington’s Disease Gene Therapy AMT-130

5 months ago talkbio0Tagged Accelerated, AMT-130, Approved, cUHDRS, gene therapy, Huntington 's disease, NEFL gene, NfL, Regenerative Medicine, RMAT, UniQure, United States Food and Drug Administration

uniQure, FDA, Accelerated Approval, Huntington’s Disease, Gene Therapy, AMT-130, cUHDRS, Neurofilament Light Chain (NfL), Regenerative Medicine Advanced Therapy (RMAT)