September 11, 2025

LB Pharmaceuticals Upsizes IPO to $285M, Marks First Major Biotech Listing in Months

9 hours ago talkbio0Tagged IPO, IPOs, LBRX, Nasdaq, Phase III, Pounds, public entity, Schizophrenia

LB Pharmaceuticals; IPO; biotech; $285 million; LBRX; schizophrenia; Phase III; public offering; Nasdaq; 2025 biotech IPOs

Intercept Withdraws Ocaliva from US Market After FDA Safety Concerns

9 hours 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

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

11 hours 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

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

11 hours 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

Merck Moves All R&D Operations Out of UK, Citing Unfavorable Environment

12 hours ago talkbio0Tagged Biological Science Disciplines, Brexit impact, Drug Discovery, Government, Investments, layoffs, London Bioscience Innovation Centre, Merck, Multiple Sulfatase Deficiency Disease, Relocation of home or business, UK

Merck; MSD; R&D relocation; UK life sciences; drug discovery; Brexit impact; London Bioscience Innovation Centre; Francis Crick Institute; government investment; layoffs

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

13 hours 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

19 hours 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