The day in pharma, read in minutes.
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NewsTelangana Merges Food Safety and Drugs Control Departments
Telangana merges food safety and drugs control into TG SAFE, tightening enforcement for the state's API and formulation manufacturers.
Sai Life Sciences Appoints Maneesh Pingle as President of Discovery Division
Modi Sets Global Top-Five Target for Indian Pharma, Raising the Compliance Bar
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Sun Pharma Secures US Court Ruling Dismissing Lipitor Antitrust Litigation
Aurobindo Gains VAI Classification for Raleigh Facility After 11-Observation Form 483
Latest news
11 storiesTCS Launches Agentic AI Platform Targeting Drug Development & Pharmacovigilance Workflows
TCS launches an Agentic AI platform targeting pharmacovigilance and drug development workflows, aiming to reduce operational burden on scientific teams.
CanSinoBIO Secures NMPA NDA Acceptance for Td5cp Adolescent & Adult Pertussis Vaccine
China's NMPA has accepted CanSinoBIO's NDA for its Td5cp adolescent and adult pertussis booster vaccine, targeting individuals aged six and above.
Abbott India Appoints Dr. Sudarshan Jain as Chairman
Abbott India appoints Dr. Sudarshan Jain as Chairman, bringing 40+ years of pharma and healthcare experience to the role.
NurExone Achieves MBP-Positive Cell Signal in ExoPTEN Spinal Cord Preclinical Program
NurExone reports MBP-positive cell increases in ExoPTEN-treated spinal cord tissue, adding mechanistic data to prior functional recovery findings.
Lantheus Gains FDA Approval for TAUKLARIFY Tau PET Imaging Agent in Alzheimer's Disease
FDA approves Lantheus's TAUKLARIFY tau PET agent for Alzheimer's, raising GMP and supply-chain questions for radiopharmaceutical manufacturers.
Gland Pharma Appoints Deepak Sapra as Chief Executive Officer
Gland Pharma names Deepak Sapra CEO, with implications for its sterile injectable GMP compliance and global manufacturing strategy.
Moleculin Biotech Achieves Threefold CR Advantage in MIRACLE Trial Ahead of 2027 NDA Path
Moleculin's MIRACLE trial shows CR rates three times higher than control; full readout due December 2026–February 2027.
Capricor Therapeutics Faces 9-3 AdCom Rejection for Deramiocel in Duchenne Cardiomyopathy
CTGTAC votes 9-3 against deramiocel for DMD cardiomyopathy; FDA decision due August 22, 2026 on BLA 125842.
Bristol-Myers Squibb Gains FDA Accelerated Approval for Iberdomide in Relapsed or Refractory Multiple Myeloma
FDA grants accelerated approval to BMS's iberdomide (Zenbexus) for RRMM, triggering mandatory REMS enrollment for specialty pharmacies and distributors.
Eton Pharmaceuticals Gains FDA Fast Track for AMGLIDIA and Targets 2027 NDA with ASN-001 Acquisition
Eton Pharmaceuticals reports 99% revenue growth in Q2 2026 while advancing FDA Fast Track, a PAS filing, and a 2027 NDA target across its rare disease pipeline.
Eledon Pharmaceuticals Gains FDA End-of-Phase 2 Alignment for Tegoprubart Ahead of Global Phase 3 Kidney Trial
Eledon secures FDA End-of-Phase 2 alignment for tegoprubart, setting the regulatory and CMC framework for a 600-patient global Phase 3 kidney transplant trial due late 2026.
Worth your time this week
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Emergent BioDefense Gains FDA Approval Letter Update for BioThrax Post-Exposure Prophylaxis Labeling
AstraZeneca Plans Regulatory Submission for Anselamimab After CARES Subgroup Data Show Survival Gains
ProQR Therapeutics Achieves First Clinical Validation of Axiomer RNA Editing Platform with AX-0810 Data
