The day in pharma, read in minutes.
NewsMedicus 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
Celmade Receives FDA Warning Letter for Unapproved Injectable Botulinum Toxin Sales into U.S.
Bentley Laboratories Receives FDA CGMP Warning Letter Citing OOS Investigation Failures and Unapproved Drugs
Akums Gains DCGI Approval for Colchicine in Cardiovascular Indication, a First in India
Latest news
11 storiesPfizer Takes 45 Oncology Studies to ESMO 2025 Congress in Madrid Across Oral and Poster Sessions
Pfizer brings 45 oncology studies to ESMO 2025, including 11 oral sessions, a pipeline signal with direct manufacturing and tech transfer implications.
AbbVie Wins FDA Approval for JUVMO in Parkinson's Disease
AbbVie's JUVMO becomes the first FDA-approved selective D1/D5 receptor agonist for Parkinson's disease, setting a new CNS regulatory benchmark.
Phathom Launches Phase 3 Vonoprazan Trial for GERD
Phathom initiates Phase 3 PRN vonoprazan study in NERD, targeting a label expansion with topline data expected Q1 2028.
Moleculin Biotech Achieves Full Part A Enrollment in Phase 2/3 AML MIRACLE Trial
Moleculin closes Part A enrollment at 89 subjects in its pivotal AML MIRACLE trial, targeting a comprehensive Q1 2027 data readout.
Epicur Pharma Receives FDA Warning Letter Over Misbranded Compounded Animal Drug Claims
FDA's Center for Veterinary Medicine cited Epicur Pharma for misbranded compounded animal drug claims, flagging website content as a direct enforcement trigger.
AbbVie Partners With Valkai to Accelerate Clinical Development
AbbVie partners with Valkai to deploy AI across clinical research, targeting faster insight generation and shorter development timelines.
Propanc Biopharma Advances GMP Manufacture and Regulatory Workstreams
Propanc Biopharma runs parallel GMP, bio-analytics, and HREC workstreams targeting a Q1 2027 Phase 1b PRP first-in-human study start.
NewAmsterdam Pharma Doses First Participant in Phase 2b SPINOZA Trial for Preclinical Alzheimer's Disease
NewAmsterdam Pharma doses first participant in SPINOZA, a genotype-stratified Phase 2b trial evaluating obicetrapib in preclinical Alzheimer's disease.
FibroBiologics Secures European Patent for Fibroblast Conditioning Methods Covering Spinal Disc Regeneration
FibroBiologics secures European Patent No. 3568465 covering fibroblast conditioning with PRP and cytokines for disc and tissue regeneration.
Kellin Chemicals Gains Adulteration Designation After Refusing FDA Facility Inspection in Zhangjiagang
FDA designates Kellin Chemicals API as adulterated after the Chinese supplier refused a preannounced inspection, triggering U.S. import detention risk.
Curia New York Receives FDA Warning Letter Over Thousands of Undocumented Chromatographic Injections
FDA issued Curia New York a warning letter citing thousands of undocumented chromatographic injections and data integrity failures at its Rensselaer API facility.
Worth your time this week
Ab Science Revises Trial Timelines After Three Gcp Inspections
Novo Nordisk Signs $2.6B Deal With Hengrui For Oral GLP-1
Teva Wins FDA Nod For DEGEVMA, Completing Denosumab Portfolio
