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NewsPharming Group Gains FDA Approval for Leniolisib in Children Aged 4–11 with APDS
FDA approves leniolisib for APDS in children aged 4–11, using PK bridging from an 8-patient study to extend the 2023 adult approval.
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
XORTX Initiates GMP Manufacturing Of XORLO™ For Dual Dossier
Latest news
11 storiesFDA, 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.
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.
Ritedose Appoints Carolyn Berg as Vice President of Strategic Growth in Sterile BFS Expansion
Ritedose appoints Carolyn Berg as VP of Strategic Growth, signaling expanded commercial push in sterile BFS ophthalmic and respiratory CDMO markets.
FDA Resurfaces ICH M3(R2) Guidance on Nonclinical Safety Studies
FDA re-surfaces ICH M3(R2) nonclinical safety guidance; regulatory teams should audit study packages against current harmonized standards.
Worth your time this week
Novo Nordisk Rebinyn Obtains Fda Approvals For Hemophilia B Cases
FDA OTAT Launches Gene Therapy CMC Town Hall Series
ProQR Therapeutics Doses First Participant in Phase 1 Study of AI-Discovered RNA Editing Candidate AX-0811
