United States Food and Drug Administration – Page 3

Amgen Builds Case for Repatha to Prevent Heart Disease With Landmark Late-Stage Data

2 weeks ago talkbio0Tagged amgen, Approved, Cardiovascular Diseases, Cardiovascular event, Cerebrovascular accident, LDL-C, Myocardial Infarction, PCSK9 inhibitor, Primary Prevention, Repatha, United States Food and Drug Administration, VESALIUS-CV trial

Amgen; Repatha; VESALIUS-CV trial; primary prevention; cardiovascular disease; PCSK9 inhibitor; LDL-C; FDA approval; major adverse cardiovascular events; heart attack; stroke

Vanda Ends Lawsuits Against FDA in Broad Settlement, Paving Way for Drug Review Progress

2 weeks ago talkbio0Tagged Clinical Trials, collaborative framework, Drug Approval, Employment Termination, Hetlioz, jet lag disorder, lawsuit, Motion Sickness, sNDA, Tradipitant, United States Food and Drug Administration, Vanda Pharmaceuticals

Vanda Pharmaceuticals; FDA; Hetlioz; jet lag disorder; tradipitant; lawsuit dismissal; collaborative framework; clinical trial hold; drug approval; sNDA; motion sickness

Despite Government Shutdown, Companies Still Plan to Submit FDA Applications

2 weeks ago talkbio0Tagged AbbVie, amgen, Application procedure, biology (field), drug applications, funding lapse, Government, J&J, Myers Squibb, Pfizer, pharmaceutical delays, shutdown, United States Food and Drug Administration, user fees

FDA shutdown; new drug applications; biologic applications; user fees; pharmaceutical delays; government funding lapse; AbbVie; Amgen; Bristol Myers Squibb; J&J; Pfizer

Fortress Biotech and Sentynl Therapeutics Fail to Secure FDA Approval for CUTX-101 in Rare Pediatric Menkes Disease

3 weeks ago talkbio0Tagged biotech, Complete, CUTX-101, deficiencies, Drug Approval, Fortress, Infrequent, Manufacturing, Menkes disease, Pediatric Disorder, Sentynl Therapeutics, United States Food and Drug Administration

Fortress Biotech; Sentynl Therapeutics; FDA Complete Response Letter; CUTX-101; Menkes disease; rare pediatric disease; manufacturing deficiencies; drug approval setback

US Government Shutdown Threatens to Stress an Already Depleted FDA

3 weeks ago talkbio0Tagged delays, Drug Approval, federal funding, Government Shutdown, public health medicine (field), regulatory, Staff, Surgical aspects, United States Food and Drug Administration, user fees

Government shutdown; FDA operations; drug approval delays; FDA staff cuts; user fees; public health; federal funding; regulatory delays

FDA Rejects CUTX-101 for Rare Copper Deficiency Due to Manufacturing Issues

3 weeks ago talkbio0Tagged biotech, CUTX-101, Cyprium Therapeutics, Fortress, Hypocupremia, manufacturing deficiencies, Menkes disease, Rejection, Sentynl, United States Food and Drug Administration

FDA rejection; Menkes disease; CUTX-101; copper deficiency; manufacturing deficiencies; Cyprium Therapeutics; Sentynl Therapeutics; Fortress Biotech

Novartis Receives FDA Approval for Rhapsido: First Oral BTK Inhibitor for Chronic Hives

3 weeks ago talkbio0Tagged Approved, Bruton 's tyrosine kinase inhibitor, BTKi, chronic hives, Chronic Spontaneous Urticaria, competition, Immunology, Novartis, Oral Therapy, remibrutinib, Rhapsido, United States Food and Drug Administration

Novartis; Rhapsido; FDA approval; Bruton’s tyrosine kinase inhibitor (BTKi); remibrutinib; chronic spontaneous urticaria (CSU); chronic hives; immunology; oral therapy; competition

Merck Makes Strong Case for Winrevair in Earlier-Stage Pulmonary Arterial Hypertension (PAH) Patients After Positive Phase 3 HYPERION Results

3 weeks ago talkbio0Tagged activin signaling, AKAP9 protein, human, Approved, Clinical Research, clinical worsening, early disease, Merck, PAH, Phase 3 trial, Sotatercept, United States Food and Drug Administration, Winrevair

Winrevair; Merck; HYPERION study; PAH; sotatercept; clinical worsening; early disease; activin signaling; FDA approval; Phase 3 trial

IO Biotech Sheds 50% of Staff After FDA Blocks Cancer Vaccine Approval Path

3 weeks ago talkbio0Tagged biotech, Cancer Vaccines, Clinical Trials, Cylembio, Financial cost, Io satellite, layoffs, melanoma, Regulatory Setback, Rejection, United States Food and Drug Administration

IO Biotech; layoffs; cancer vaccine; FDA rejection; Cylembio; Phase 3 trial; melanoma; regulatory setback; cost cutting; clinical trial

Enanta Presses Ahead with RSV Drug Zelicapavir Despite Missing Primary Endpoint in Phase IIb Trial

3 weeks ago talkbio0Tagged Clinical Trials, Congestive heart failure, COPD, development aspects, Elderly (population group), Enanta, Hospitalization, Neoplasm Metastasis, Phase II B Trial, primary endpoint, rates, Respiratory syncytial virus, United States Food and Drug Administration, Zelicapavir

Enanta Pharmaceuticals; RSV; zelicapavir; Phase IIb trial; primary endpoint miss; secondary endpoints; clinical trials; FDA Fast Track; elderly; COPD; congestive heart failure; hospitalization rates; future development