regulatory
Applied Therapeutics Undergoes Leadership Changes Amid FDA Rejection and Regulatory Challenges
Applied Therapeutics, leadership changes, FDA rejection, rare disease drug, govorestat, regulatory challenges
Novo Holdings to Finalize $16.5B Acquisition of Catalent Following Regulatory Clearance
Novo Holdings, Catalent, Acquisition, Regulatory Clearance, Life Sciences, Pharmaceutical Development
Navigating JPM Week 2024: Insights and Opportunities in Biopharma
JPM Week 2024, Biopharma, Industry Insights, Networking, Deal-making, Investment, M&A, IPOs, Regulatory Trends
GSK Advances Regulatory Filings for Linerixibat Following Successful Phase 3 Trial in PBC Itch Treatment
GSK, Linerixibat, PBC Itch, Phase 3 Trial, Regulatory Filings, Cholestatic Pruritus
Merck’s Subcutaneous Keytruda Shows Non-Inferiority in Phase 3 Trial, Paving Way for Regulatory Discussions
Merck, Keytruda, subcutaneous, cancer immunotherapy, phase 3 trial, non-inferiority, regulatory submissions
GSK’s Blenrep Demonstrates Survival Advantage Over J&J’s Darzalex in Multiple Myeloma Treatment
GSK, Blenrep, Belantamab mafodotin, Multiple myeloma, DREAMM-7, DREAMM-8, Darzalex, Survival advantage, Regulatory challenges
Rapport Therapeutics Faces Regulatory Hurdles in Pain Treatment Trials
Rapport Therapeutics, pain treatment trials, regulatory challenges, RAP-219, clinical development
Dr. Reddy’s Recalls Over 300,000 Bottles of Thyroid Medication Due to Carcinogen Contamination
Dr. Reddy’s, thyroid drug recall, carcinogen contamination, pharmaceutical safety, FDA regulations
Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting
Lexicon Pharmaceuticals, Zynquista, FDA, diabetes drug, advisory committee, regulatory challenges
Mitigating Risks in mRNA Manufacturing: Strategies for Smooth Transition from Preclinical to Clinical Stages
mRNA manufacturing, risk management, preclinical to clinical transition, quality control, regulatory compliance, raw material selection, process automation, analytical methods.