United States Food and Drug Administration – Page 7

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

FDA Begins Publishing Complete Response Letters for Ongoing Drug Applications in Real Time

1 month ago talkbio0Tagged Application procedure, drug applications, openFDA, public health medicine (field), radical transparency, real-time disclosure, regulatory transparency, Response Letters, United States Food and Drug Administration

FDA; complete response letters; real-time disclosure; drug applications; radical transparency; pending applications; regulatory transparency; public health; openFDA

Hikal Receives US FDA Warning Letter Over Metal Contamination at Jigani Facility

1 month ago talkbio0Tagged adulteration, alpha 1-antitrypsin, Cautionary Warning, GMP violations, Hikal, India, Jigani Facility, Letter [Publication Type], Manufacturer, Metals, pharmaceutical manufacturing, Regulatory Compliance, United States Food and Drug Administration

Hikal; FDA warning letter; metal contamination; API manufacturer; GMP violations; Jigani facility; India; pharmaceutical manufacturing; regulatory compliance

Avidity Touts Functional Improvements for DMD Therapy, Clearing Way to FDA

1 month ago talkbio0Tagged Approved, Avidity, Biosciences, Blackfoot language, Breakthrough Therapy, Clinical Trials, Functional, Improvements, Muscular Dystrophy, Duchenne, skipping, Submission, United States Food and Drug Administration

Avidity Biosciences; del-zota; DMD; Duchenne muscular dystrophy; FDA approval; functional improvements; exon 44 skipping; Breakthrough Therapy; clinical trial; BLA submission

PMV Pharma’s p53 Drug Shows Effect in Ovarian Cancer, but Financial Challenges Loom

1 month ago talkbio0Tagged cash runway, Clinical Trials, Familial mitral valve prolapse, File (record), Frequency of Responses, Funding, ovarian neoplasm, TP53 gene, United States Food and Drug Administration

PMV Pharmaceuticals; rezatapopt; p53; ovarian cancer; clinical trial; response rate; FDA filing; funding; cash runway

Trump Administration Weighs Severe Restrictions on US Pharmas Licensing Chinese Medicines

1 month ago talkbio0Tagged AstraZeneca, chinese medicine, Drug Industry, drug manufacturing, executive order, licensing restrictions, lobbying, National Security, Pfizer, Transplant Registry Unified Management Program, United States Food and Drug Administration

Trump administration; Chinese medicines; executive order; pharmaceutical industry; licensing restrictions; national security; lobbying; Pfizer; AstraZeneca; biotech; drug manufacturing; FDA review

J&J’s Inlexzo Bladder Cancer Therapy Wins ‘Practice-Changing’ FDA Approval

1 month ago talkbio0Tagged Approved, BCG-Unresponsive, Carcinoma, Drug Delivery Systems, gemcitabine intravesical system, in situ, Inlexzo, Johnson & Johnson, Malignant neoplasm of urinary bladder, New, Non-Muscle Invasive Bladder Neoplasms, SunRISe-1 trial, United States Food and Drug Administration

Inlexzo; FDA approval; bladder cancer; Johnson & Johnson; gemcitabine intravesical system; BCG-unresponsive; non-muscle invasive bladder cancer; SunRISe-1 trial; novel drug delivery; carcinoma in situ

Regeneron and Sandoz Settle Eylea Biosimilar Patent Dispute

1 month ago talkbio0Tagged Approved, Biosimilars, Enzeevu, Eylea, launch, Ophthalmology specialty, Patent Settlement, Regeneron, sandoz, United States, United States Food and Drug Administration

Regeneron; Sandoz; Eylea; Enzeevu; biosimilar; aflibercept; patent settlement; FDA approval; U.S. launch; ophthalmology