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NewsNeilMed Pharmaceuticals Receives FDA Warning Letter Over Glycerin Identity Testing Failures at Santa Rosa Facility
FDA cited NeilMed Pharmaceuticals for glycerin identity testing failures and unqualified supplier use, flagging DEG/EG contamination risk in OTC drug manufacturing.
NeilMed Pharmaceuticals Secures FDA Warning Letter Closeout After Three-Year CAPA Recovery
FDA Issues Draft Guidance on BLA Submissions for Individualized Genome Editing Products
Beaute Bounty Receives FDA CBER Warning Letter for Unlicensed Stem Cell and Placenta Biologics
FDA Issues Warning Letter to Best Chinese Medicines LLC Over Five Unapproved Drug Products
Latest news
11 storiesAlembic Pharmaceuticals Gains USFDA Final Approval for Valganciclovir Oral Solution in CMV Retinitis
Alembic Pharmaceuticals receives USFDA final approval for Valganciclovir oral solution, indicated for CMV retinitis in AIDS patients.
AbbVie Submits BLA for Etentamig to FDA for Relapsed/Refractory Multiple Myeloma
AbbVie files BLA for etentamig, a BCMA x CD3 bispecific antibody, backed by Phase 3 CERVINO data showing 74% ORR in relapsed/refractory multiple myeloma.
World's Biggest Microbiology & CCS Summit ‘Pharmig India 2026’ Unites Global Microbiology & CCS Leaders in Hyderabad
Pharmig India 2026 returns to Hyderabad on December 3–4, focusing on microbiology, Annex 1 and contamination control.
Bristol Myers Squibb Achieves Phase 3 Progression-Free Survival in Lung Cancer
BMS's EGFRxHER3 bispecific ADC nearly doubles progression-free survival in Phase 3 lung cancer trial, raising GMP and scale-up questions.
Roche Achieves 44% Mortality Reduction with Divarasib in Phase III KRAS-Mutant Lung Cancer Trial
Roche's divarasib cut mortality risk by 44% in a Phase III KRAS G12C lung cancer trial, raising immediate CMC and regulatory submission questions.
Merck Achieves Sustained Tumour Response with Pimicotinib in Phase 3 PVNS Trial
Merck's pimicotinib delivers durable tumour responses in PVNS Phase 3 data, advancing orphan oncology programme toward regulatory submission.
Darolutamide Achieves 58% Metastasis Risk Reduction in Phase III High-Risk Prostate Cancer Trial
Phase III data show darolutamide cuts metastasis or death risk by 58% in high-risk localised prostate cancer, raising CMC and regulatory submission timelines.
Roche Achieves 43.1% Proteinuria Reduction with Sefaxersen in Phase III IgA Nephropathy Trial
Roche's sefaxersen cut proteinuria by 43.1% in Phase III IgA nephropathy trial, advancing the oligonucleotide therapy toward regulatory submission.
Lilly Achieves Durable Early Responses with Olomorasib in KRAS-Targeted Lung Cancer Trial
Lilly's KRAS inhibitor olomorasib shows durable early-stage responses in lung cancer, signalling potential regulatory fast-track and CMC planning implications.
BioNTech and Bristol Myers Squibb Report 36.7% Response Rate for Pumitamig in Lung Cancer
BioNTech and BMS report 36.7% response rate for pumitamig plus docetaxel in lung cancer, signaling a potential regulatory filing timeline.
Zydus's Moraiya plant closes FDA inspection with 5 observations
Zydus Lifesciences' Moraiya plant closed a 5–13 October 2026 FDA inspection with five observations. What the disclosure says, what it leaves out, and what comes next.
Worth your time this week
Pfizer Gains FDA Approval for Talazoparib Plus Enzalutamide in HRR-Mutated mAPMN/S Prostate Cancer
Hepion Pharmaceuticals Gains FDA Backing for GV104 Modeling
FDA Extends Coral Snake Antivenin Lot CL6814 to December 2026
