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NewsCPHI Milan Pharma Awards 2026 Finalists Announced
Informa Markets reveals CPHI Pharma Awards 2026 finalists across 15 categories, celebrating innovation in drug development, digital transformation, and sustainability.
Pharming Group Gains FDA Approval for Leniolisib in Children Aged 4–11 with APDS
Lonza Builds Oregon Spray-Drying Facility To Expand SDD Capacity
China NMPA Accepts Nicox NCX 470 NDA; Decision In 18 Months
Hitaka To Present Axcelead GLP-1 Rodent Nausea Data At Obesity 26
Latest news
11 storiesXORTX Initiates GMP Manufacturing Of XORLO™ For Dual Dossier
XORTX begins GMP manufacturing of XORLO™, structuring CMO batches to supply XRX-OXY-102 and build NDA validation data concurrently.
FDA, NIH & CDC Host Workshop On Valley Fever Vaccine Pathway
FDA, NIH, and CDC workshop maps regulatory and manufacturing gaps for Valley fever vaccines, with implications for biologics developers and CMOs.
Medical Action Recalls Epidural Kits Over Sterility Risk
Medical Action Industries issues Class I correction for epidural kits after Huons sterility failure cascades through Spectra Medical Devices to kit level.
Roche Cobas Malaria Test Gets FDA Approval For Donor Screening
FDA clears Roche cobas Malaria NAT for individual donor screening on cobas 6800/8800, expanding biologics testing obligations for blood and organ programs.
FDA OTAT Launches Gene Therapy CMC Town Hall Series to Guide IND and BLA Submissions
FDA OTAT's inaugural gene therapy CMC town hall sets submission expectations for IND and BLA sponsors in advanced therapy manufacturing.
Cosette Pharmaceuticals Appoints Andrew Adams as Vice President of Supply Chain and Sourcing
Cosette Pharmaceuticals names Andrew Adams VP of Supply Chain & Sourcing to support portfolio expansion into complex and sterile dosage forms.
AbbVie Achieves Phase 3 Primary and All Secondary Endpoints for Atogepant in Menstrual Migraine
AbbVie's Phase 3 LUNA study met all endpoints for atogepant in menstrual migraine, setting up a new indication filing with distinct CMC implications.
FDA Removes PABA and Trolamine Salicylate from OTC Sunscreen Monograph in September 2026 Final Order
FDA's final order removes PABA and trolamine salicylate from OTC Monograph M020; labeling, SPF limits, and dosage forms remain open.
Roche Gains FDA Priority Review for Enspryng sBLA in MOGAD with Decision Due January 2027
FDA grants Priority Review for Roche's Enspryng sBLA in MOGAD; decision expected 10 January 2027 for the potential first approved therapy.
Medicus Pharma Identifies 200 µg D-MNA Dose as Lead in Phase 2 SkinJect CSR for Basal Cell Carcinoma
Medicus Pharma posts abridged Phase 2 CSR for SkinJect, naming 200 µg D-MNA patch as pivotal dose for its FDA-authorized Gorlin syndrome NDA program.
Sarborg Applies Quantum Computing and Signature Intelligence Models to Neuropsychiatric Drug Discovery
Sarborg applies quantum computing and Signature Intelligence models to neuropsychiatric discovery; CDT Equity holds 22.7% stake in the platform.
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Ritedose Appoints Carolyn Berg as Vice President of Strategic Growth in Sterile BFS Expansion
FDA Resurfaces ICH M3(R2) Guidance on Nonclinical Safety Studies
Novo Nordisk Rebinyn Obtains Fda Approvals For Hemophilia B Cases
