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NewsEurofins SF Analytical Laboratories Receives FDA Warning Letter for Microbial Data Integrity Failures at Horsham Facility
FDA cites Eurofins SF Analytical Labs for CGMP failures including unrecorded TNTC results and missing 0-CFU secondary verification at its Horsham, PA site.
Lovelace Biomedical Receives FDA Warning Letter Over GLP Raw Data Reconciliation Failures
Hanlim Pharm Receives FDA Warning Letter After Aseptic Failures Found at Sterile Fill-Finish Facility
SCA Pharmaceuticals Receives FDA Warning Letter Citing Sterile Compounding CGMP Failures at 503B Facility
Bristol Myers Squibb’s RYZ101 Meets Phase 3 Endpoint in GEP-NETs
Latest news
11 storiesPhio Pharmaceuticals Completes First Commercial-Scale cGMP Batch of PH-762 Drug Substance Ahead of Phase 2b
Phio Pharmaceuticals releases first commercial-scale cGMP batch of PH-762 API, supporting Phase 2b trial initiation targeted for Q1 2027.
Lonza Signs Exclusive Deal with Qurient to Advance Dual-Payload ADC Cancer Therapies
Lonza's exclusive deal with Qurient targets dual-payload ADC manufacturing, raising containment and process validation demands for CDMO operators.
Perceptive Discovery Partners With Nucleus RadioPharma, Accelerate Radiopharmaceutical Development
Perceptive Discovery and Nucleus RadioPharma formalize a referral partnership to streamline radiopharmaceutical programs across the development continuum.
Zydus and Formycon Secure FDA Acceptance for First Pembrolizumab Biosimilar
FDA accepts the first biosimilar BLA referencing pembrolizumab, filed jointly by Zydus and Formycon, opening the regulatory pathway for PD-1 biosimilars.
Dr. 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
Cadila Pharmaceuticals appoints Nirav Gandhi as President, a move with implications for GMP compliance and US market regulatory strategy.
FDA Updates Phase 1 IND FAQ, Clarifying Clinical Hold Triggers and Nonclinical Data Requirements
FDA's updated Phase 1 IND FAQ clarifies clinical hold triggers, nonclinical data requirements, and IND exemption criteria for first-in-human submissions.
FDA Approves Hovilpri for Immunocompromised Adults with Treatment-Resistant HSV Lesions
FDA approves Hovilpri (pritelivir) for immunocompromised adults with HSV lesions resistant to standard antivirals, backed by a Phase 3 superiority trial.
CPHI Pharma Awards 2026 winners announced in Milan
CPHI Pharma Awards 2026 honours winners across 15 categories for innovation in drug development, manufacturing, sustainability, supply chain, and leadership.
SPI 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
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