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NewsEMA Sets Deadline for Women's Health Regulatory Roadmap After Amsterdam Workshop
EMA targets Q4 2026 for a women's health regulatory roadmap, signalling new expectations on trial design and sex-disaggregated data.
AbbVie Achieves Phase 1 Milestone for ABBV-295 Amylin Analog Supporting Monthly Dosing Intervals
Roche's Fenebrutinib Gets FDA Priority Review For RMS And PPMS
AbbVie's Zumilokibart Hits Phase 2 Endpoint For Atopic Dermatitis
AstraZeneca Secures 12% Stake In Summit For $2B Ivonescimab Asset
Latest news
11 storiesLilly Foundayo Outperforms Oral Semaglutide In Weight Loss Trials
Indirect analysis of ACHIEVE-3 and PIONEER PLUS data positions Lilly's Foundayo ahead of oral semaglutide on weight loss, with manufacturing scalability implications for both molecules.
Novo Nordisk Signs $2.6 Billion Deal with Hengrui for Oral GLP-1 Candidate
Novo Nordisk licenses Hengrui's oral GLP-1 candidate for up to $2.6B, signalling a manufacturing pivot toward solid-dose in the weight-loss drug space.
FDA & CRCG Host December 2026 LAI Generics Workshop On ANDA Gaps
FDA and CRCG host a two-day LAI generics workshop in December 2026, targeting IVRT, bioequivalence, and ANDA deficiency patterns for complex injectables.
FDA Charges Two Indian Nationals In Fake Ozempic Ring
FDA charges two Indian nationals in a counterfeit Ozempic scheme, exposing distributor due diligence gaps across U.S. pharma supply chains.
Telix Secures FDA Fast Track For BiPASS Prostate Cancer Program
Telix gains FDA Fast Track for BiPASS 68Ga-PSMA-PET program, accelerating NDA pathway for pre-biopsy prostate cancer imaging.
Zealand Petrelintide Hits Double Digit Weight Loss In Phase Two
Zealand Pharma's petrelintide hit 10.7% weight loss in Phase 2 ZUPREME-1, with Phase 3 manufacturing scale-up now in scope.
MaaT Pharma Shifts MaaT034 To FDA Path After Xervyteg EU Rejection
CHMP upholds negative opinion on Xervyteg® after re-examination; MaaT Pharma schedules FDA CMC pre-IND for MaaT034 in October 2026.
Medicus Pharma Submits Phase 2b/3 Teverelix Protocol to FDA
Medicus Pharma files a seamless Phase 2b/3 protocol for Teverelix, targeting a ~600-patient registration pathway ahead of planned out-licensing.
Fresenius Kabi Receives FDA Warning Letter After Aseptic Processing Investigation Failures at Melrose Park Facility
FDA issues warning letter to Fresenius Kabi AG over aseptic processing investigation failures and a famotidine recall at its Melrose Park sterile injectables site.
Celmade Receives FDA Warning Letter for Unapproved Injectable Botulinum Toxin Sales into U.S.
FDA issued a warning letter to South Korea-based Celmade for selling unapproved injectable botulinum toxin into the U.S. market via two commercial websites.
Bentley Laboratories Receives FDA CGMP Warning Letter Citing OOS Investigation Failures and Unapproved Drugs
FDA issued a CGMP warning letter to Bentley Laboratories citing OOS investigation failures and two unapproved OTC drug products.
Worth your time this week
Akums Gains DCGI Approval for Colchicine in Cardiovascular Indication, a First in India
Pfizer Takes 45 Oncology Studies to ESMO 2025 Congress in Madrid Across Oral and Poster Sessions
AbbVie Wins FDA Approval for JUVMO in Parkinson's Disease
