The day in pharma, read in minutes.
NewsDr. Reddy's Gains Brazil Approval for Generic Semaglutide Injection
ANVISA clears Dr. Reddy's generic semaglutide injection for type 2 diabetes, opening a referenceable regulatory pathway for GLP-1 generics in Brazil.
Janssen Gains FDA Approval for Erdafitinib in Urothelial Carcinoma
Xcovery Holdings Gains FDA Approval for Ensartinib in ALK-Positive Metastatic NSCLC
Checkpoint Therapeutics Gains FDA Approval for Cosibelimab-ipdl
Janssen Gains Traditional FDA Approval for Rybrevant in First-Line EGFR NSCLC
Latest news
11 storiesFDA 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.
Ipsen Gains FDA Approval for Onivyde in First-Line Metastatic Pancreatic Adenocarcinoma
FDA approved Ipsen's Onivyde in first-line metastatic pancreatic adenocarcinoma, expanding GMP manufacturing demand for a complex liposomal formulation.
Pfizer Gains FDA Approval for Besponsa in Pediatric Relapsed or Refractory ALL Patients
FDA approved Pfizer's Besponsa for pediatric ALL patients aged 1+, with 42% CR rate and 95.5% MRD negativity in a 53-patient study.
FDA Approves Genentech's Inavolisib Triplet with Companion Diagnostic
FDA approved Genentech's inavolisib triplet regimen alongside the FoundationOne Liquid CDx companion diagnostic, creating co-dependent regulatory obligations for QA and regulatory teams.
GSK Gains FDA Approval for Blenrep in Relapsed or Refractory Multiple Myeloma
FDA approves GSK's Blenrep for relapsed/refractory multiple myeloma, reinstating BLENREP REMS with strict ocular monitoring requirements.
Janssen Gains FDA Approval for Subcutaneous Rybrevant Faspro
FDA approves Janssen's subcutaneous Rybrevant Faspro, with PK bridging data setting a comparability benchmark for IV-to-SC biologics transitions.
Incyte Gains FDA Approval for Axatilimab-csfr in cGVHD
FDA approved Incyte's axatilimab-csfr for refractory cGVHD under Orphan Drug and Fast Track designations, with a 75% ORR in pivotal trial data.
Janssen Gains FDA Approval for Inlexzo Intravesical System in Bladder Cancer
Janssen's Inlexzo gains FDA approval for BCG-unresponsive NMIBC, setting a precedent for dual drug-device regulatory oversight in oncology.
FDA OHA Guidance Agenda Covers Rare Disease and Product Reviews
FDA's OHA has structured a 2025 guidance agenda covering combination products, rare disease incentives, and clinical trial oversight.
Moderna Achieves Phase 2/3 Recommendation for mRNA Ebola Vaccine
WHO's TAG-CVP has recommended Moderna's mRNA Ebola vaccine advance to Phase 2/3 trials in DR Congo, raising scale-up and cold-chain questions for manufacturers.
Worth your time this week
MaaT Pharma Achieves Primary Safety Endpoint in PICASSO Trial
FDA Reports 720 Generic Approvals Amid Pricing Pressure
Rigel Launches VEPPANU as First FDA-Approved PROTAC Therapy
