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NewsDr. Reddy's FTO-11 Plant Receives Two FDA Form 483 Observations After Andhra Pradesh Inspection
Dr. Reddy's FTO-11 site in Andhra Pradesh received two FDA Form 483 observations, raising inspection-readiness questions for Indian pharma exporters.
Cadila Pharmaceuticals Appoints Nirav Gandhi as President Amid US Market Push
FDA Updates Phase 1 IND FAQ, Clarifying Clinical Hold Triggers and Nonclinical Data Requirements
FDA Approves Hovilpri for Immunocompromised Adults with Treatment-Resistant HSV Lesions
CPHI Pharma Awards 2026 winners announced in Milan
Latest news
11 storiesSPI Pharma Unveils New Brand Identity and Formulation Focus
SPI Pharma unveils new brand identity and tagline, reinforcing its focus on formulation innovation ahead of CPHI Worldwide 2026.
Dec Group Showcases Breakthrough Technologies for Aseptic Processing, Lyophilization and Bioprocessing at CPHI Milan 2026
Dec Group will showcase Rheofreed®, DecFill® XP, single-use bioreactor and PTS powder transfer technologies at CPHI Milan 2026.
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Biological 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
Zydus Lifesciences extends its Sunshine Healthcare Lanka JV investment deadline to December 2026, keeping a 50% equity stake transaction in play.
Godavari Biorefineries Secures Mexican Antiviral Patent
Godavari Biorefineries secures a Mexican patent for antiviral compounds, extending its IP portfolio into Latin America.
Bayer Commits $2.2 Billion To New U.S. Sites Amid Reshoring Drive
Bayer's $2.2B U.S. site investment brings its five-year domestic pharma spend to $9.2B, with site details still pending.
FDA Plant Inspection Delays Novo Nordisk Denecimig BLA Review Now
FDA extends Novo Nordisk's denecimig BLA review citing facility remediation, with no new action date set and a 2027 US launch still targeted.
FDA 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.
Worth your time this week
FDA Releases Transparency Roadmap With Complete Response Letters Now
Lilly Achieves Oral GLP-1 Risk Reduction Data Signaling Solid Dosage Scale-Up Demand
TAPI Appoints Serge Rogasik as CEO to Drive Global API and CDMO Expansion
