The day in pharma, read in minutes.
NewsKaryopharm Signs Merger Agreement with Ayrmid
Karyopharm files Chapter 11 and names Ayrmid as lead merger bidder, raising supply and regulatory continuity questions for selinexor.
Dr. Reddy's Gains Tentative USFDA Approval for Generic Lenacapavir
FDA Issues Final Potency Assurance Guidance for Cell and Gene Therapy Manufacturers
Tonix Pharmaceuticals Appoints George Lederman as EVP of Strategy and Transformation
Spektus Pharma Signs Global Commercialisation Deal with GEBRO for ActraFlex
Latest news
11 storiesGlenmark Pharmaceuticals Appoints Namita Shah as Senior Vice President
Glenmark elevates Namita Shah to SVP – Global Portfolio, expanding her remit from India and emerging markets to a worldwide scope.
Granules India Completes USFDA Inspection at Gagillapur with 11 Observations Issued
Granules India's Gagillapur facility received 11 USFDA observations; the company confirms no data integrity or cross-contamination findings.
Zydus Appoints Christoph Stoller to Lead International Markets
Zydus appoints Christoph Stoller, former Glenmark EMEA/LATAM/APAC head, to lead its International Markets Business unit.
Alembic Wins USFDA Final Approval for Venetoclax in CLL/SLL
Alembic Pharmaceuticals secures USFDA final approval for generic Venetoclax tablets, entering the CLL/SLL oncology market after clearing complex bioequivalence requirements.
Sun Pharma Secures FDA Approval for ILUMYA in Psoriatic Arthritis
Sun Pharma's sBLA for ILUMYA wins FDA approval, expanding the biologic's label into psoriatic arthritis beyond its existing plaque psoriasis indication.
FDA Funds Digital Biomarker Projects in ALS, CMT and Huntington's
FDA-funded DHT projects at MGH, Biosensics, and U of Rochester advance wearable endpoint validation for ALS, CMT, and Huntington's disease submissions.
FDA Approves Voceryq, First Plasmid DNA Immunotherapy for RRP
FDA grants accelerated approval for Voceryq, the first plasmid DNA-based immunotherapy in the U.S., raising immediate GMP and CBER inspection implications.
FDA Updates Minocycline Breakpoints for S. maltophilia
FDA updates minocycline breakpoints for Stenotrophomonas maltophilia; regulatory teams must review labeling alignment with new MIC and disk diffusion thresholds.
Viatris Launches $1.65B Tender Offer for Pacira BioSciences
Viatris commences $36.50/share tender offer for Pacira BioSciences, with liposomal manufacturing integration posing key GMP and quality system implications.
EMA PRAC Opens Class-Wide Review of Human Immunoglobulin Safety
EMA PRAC opens class-wide review of human normal immunoglobulins after batch-linked hypersensitivity clusters prompt recalls across EU Member States.
FDA Reinforces Risk-Based Inspections Across U.S. Drug Plants
FDA's risk-based inspection model applies to all U.S.-market drug manufacturers; QA teams must align CGMP readiness with both surveillance and for-cause inspection triggers.
Worth your time this week
FDA Advances FRAME and AMTDP for AI-Driven Drug Manufacturing
Celularity Signs Exclusive Deal with Vesalius Longevity Labs
FDA Opens eCTD v4.0 Sample Submission Pathway for Drug Sponsors
