The day in pharma, read in minutes.
NewsArtelo Biosciences Achieves 40% Weight Loss in GLP-1 Combination Nonclinical Study
Artelo's ART27.13 achieves ~40% weight loss combined with semaglutide in nonclinical model; U.S. patent protection expected through 2041.
Grace Therapeutics Advances Dual-Source CMO Strategy
Monopar Therapeutics Advances Rolling NDA Submission in Wilson Disease
Kiora Pharmaceuticals Advances KIO-401 IND Pathway
Johnson & Johnson Achieves Second Phase 3 Win for CAPLYTA in Bipolar I Mania
Latest news
11 storiesFDA Finalizes GFI #273 Defining Durations of Use for Veterinary Antimicrobial Drugs in Food-Producing Animals
FDA's GFI #273 sets duration-of-use recommendations for veterinary antimicrobials, raising the compliance bar for animal drug sponsors.
ProQR Therapeutics Advances RNA Editing Pipeline
ProQR reports full enrollment in AX-0811 Phase 1 cohorts and targets multiple clinical milestones through H1 2027, with €103M cash runway into mid-2028.
FibroBiologics Expands Fibroblast IP Portfolio to 170 Issued Patents
FibroBiologics reaches 170 issued patents covering fibroblast therapeutics and manufacturing methods, raising IP complexity for CDMOs entering the space.
Dr. Reddy's Secures Brazil Approval for Generic Semaglutide
ANVISA clears Dr. Reddy's generic semaglutide injection for type 2 diabetes, opening a referenceable regulatory pathway for GLP-1 generics in Brazil.
Janssen Wins Full FDA Approval for Erdafitinib
Janssen's erdafitinib converts to full FDA approval in FGFR3-altered urothelial carcinoma, narrowing the indication and reshaping CDx and labeling obligations.
FDA Approves Ensartinib for ALK-Positive Metastatic NSCLC
FDA approves Xcovery's ensartinib for ALK-positive NSCLC, triggering commercial GMP scale-up obligations for the first-time commercial sponsor.
Checkpoint Therapeutics Gains FDA Approval for Cosibelimab-ipdl
FDA approves Checkpoint Therapeutics' cosibelimab-ipdl for advanced CSCC, raising GMP and fill-finish considerations for a 1,200 mg IV biologic.
Janssen Gains Traditional FDA Approval for Rybrevant in NSCLC
FDA grants Janssen traditional approval for Rybrevant in first-line EGFR exon 20 NSCLC, converting prior accelerated status via RTOR and Project Orbis.
FDA Investigates Oncogenesis Cases Linked to Novartis Zolgensma
FDA confirms insertional oncogenesis cases linked to Zolgensma, triggering review of labeling and long-term follow-up obligations across AAV gene therapy programs.
FDA Approves Lutathera for Pediatric GEP-NETs Aged 12+
FDA approves Lutathera for pediatric GEP-NET patients aged 12+, setting new GMP and post-marketing benchmarks for radiopharmaceutical manufacturers.
FDA Approves Ipsen's Onivyde for First-Line Pancreatic Cancer
FDA approved Ipsen's Onivyde in first-line metastatic pancreatic adenocarcinoma, expanding GMP manufacturing demand for a complex liposomal formulation.
Worth your time this week
Pfizer Gains FDA Approval for Besponsa in Pediatric ALL
FDA Approves Genentech's Inavolisib Triplet with Companion Diagnostic
GSK Blenrep FDA Approval Triggers REMS Ocular Monitoring
