The day in pharma, read in minutes.
NewsBiological E Appoints V Krishnakumar CEO Of Global Biopharma CDMO
Biological E names V Krishnakumar CEO of its biopharma CDMO unit, covering ADCs, mAbs, mRNA, vaccines, and recombinant proteins.
Zydus Extends Sunshine Healthcare JV Timeline To December 2026
Godavari Biorefineries Secures Mexican Antiviral Patent
Bayer Commits $2.2 Billion To New U.S. Sites Amid Reshoring Drive
FDA Plant Inspection Delays Novo Nordisk Denecimig BLA Review Now
Latest news
11 storiesFDA Approves Lilly Pirtobrutinib For First Line CLL SLL Patients
FDA approves Eli Lilly's pirtobrutinib for first-line CLL/SLL, expanding the indication with new labeling warnings and orphan drug manufacturing obligations.
FDA Updates Deviation Codes For Biologics Effective October 2026
FDA revised HCT/P and non-blood biologics deviation reporting codes on Oct 1, 2026. QA teams must update submissions before the next reporting cycle.
FDA Updates Blood Product Deviation Codes Effective October 2026
FDA CBER revised blood product deviation codes effective October 1, 2026. QA teams must update deviation systems before next submission cycle.
AbbVie Joins HRSA 340B Rebate Pilot For Three Drugs January 2027
AbbVie joins HRSA's 340B Rebate Model Pilot for IMBRUVICA, LINZESS, and VRAYLAR, launching January 2027 via the Beacon platform.
FDA Releases Transparency Roadmap With Complete Response Letters Now
FDA's Transparency Roadmap mandates CRL disclosure and sets FY27 priorities, reshaping submission planning for RA directors and QA teams.
Lilly Achieves Oral GLP-1 Risk Reduction Data Signaling Solid Dosage Scale-Up Demand
Lilly's oral GLP-1 candidate shows strongest diabetes and CV risk reduction at 17.2 mg, raising solid dosage scale-up and CMO capacity questions.
TAPI Appoints Serge Rogasik as CEO to Drive Global API and CDMO Expansion
TAPI names Serge Rogasik CEO to lead its global API and CDMO business across an international manufacturing and R&D network.
Roche Real-World Data Confirm Faricimab Durability Across Multiple Retinal Disease Indications
Roche real-world data confirm faricimab durability in nAMD, with implications for biologic batch consistency and post-approval commitments.
Roche Achieves Significant PFS Benefit with Giredestrant in Phase 3 ER+/HER2- Breast Cancer Trial
Roche's giredestrant meets Phase 3 PFS endpoint in ER+/HER2- breast cancer, with ESR1 subgroup data signaling complex regulatory and manufacturing implications.
Teva Presents Ecopipam Phase 3 and OLE Data Supporting FDA Priority Review for Pediatric Tourette Syndrome
Teva's ecopipam shows 69.8% tic reduction at 8 weeks and sustained efficacy at 18 months, with FDA Priority Review underway.
Teva Gains Journal Validation for Ecopipam's First-in-Class D1 Mechanism in Pediatric Tourette Syndrome
Teva's ecopipam D1 antagonist gains peer-reviewed support in pediatric Tourette syndrome, with Phase 3 data showing 50% relapse reduction.
Worth your time this week
FDA Hosts ICH M15 Webinar to Clarify Model-Informed Drug Development Submission Standards on October 29
Bristol Myers Squibb Gains FDA Pediatric Approval for Camzyos in Obstructive Hypertrophic Cardiomyopathy
Bespak Expands Nasal Drug Delivery Portfolio with NasaDose Ultra
