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NewsSanofi Appoints Archana Subramanya as Head of R&D India Hub
Sanofi appoints Archana Subramanya, former GSK Global Regulatory Centers head, to lead its R&D India Hub.
Kiora Pharmaceuticals Advances KIO-301 Phase 2 Enrollment Toward Coordinated Global Phase 3 Strategy
Emcure Pharma Reports 23% Revenue Rise to Rs 2,580 Crore in Q1 FY2026
FDA CBER OTP Convenes Town Hall on CMC Readiness Standards for Gene Therapy BLA Submissions
FDA Grants Accelerated Approval to Tudriqev for Anti-PD-1 Refractory Advanced Melanoma
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Latest news
11 storiesGlobal Calcium Pvt. Limited Receives FDA Warning Letter Over Falsified Batch Records and Deleted Electronic Files
FDA issued a warning letter to Global Calcium Pvt. Limited after inspectors found falsified batch records and deleted electronic files at its Tamil Nadu API facility.
Global Calcium Secures FDA Warning Letter Closure After Corrective Action Review
FDA closes Warning Letter 320-25-30 for Global Calcium Pvt. Limited, with future inspections set to assess sustainability of corrections.
Replimune Gains FDA Accelerated Approval for Tudriqev with Nivolumab in Unresectable Melanoma
FDA grants Replimune accelerated approval for Tudriqev plus nivolumab in PD-1-refractory unresectable melanoma, with confirmatory trials required.
Zentalis Pharmaceuticals Secures FDA Alignment on Azenosertib Dose After Type D Meeting for Accelerated Approval
Zentalis secures FDA dose alignment via Type D meeting for azenosertib, keeping accelerated approval on track ahead of a 1H 2027 DENALI readout.
Cognition Therapeutics Achieves FDA Design Clarity for Zervimesine Phase 3 Study in DLB Psychosis
Cognition Therapeutics confirms FDA design discussions for zervimesine Phase 3 in DLB psychosis, targeting mid-2027 initiation with a revised tablet formulation.
Aclaris Therapeutics Gains FDA Fast Track Designation for Modzatinib in Moderate to Severe Lichen Planus
FDA grants Fast Track Designation for Aclaris's modzatinib in lichen planus, enabling rolling NDA review ahead of a planned Q4 2026 Phase 2b trial.
FDA Orange Book Data Files Updated, Giving Regulatory Teams Structured Access to TE Codes and Patent Records
FDA Orange Book data files offer regulatory teams structured, monthly-updated access to TE codes, patent records, and RLD designations via ZIP download and openFDA API.
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Phio Pharmaceuticals Initiates Commercial-Scale API Manufacturing for siRNA Candidate PH-762 Ahead of FDA Meeting
Phio Pharmaceuticals initiates commercial-scale API manufacturing for siRNA candidate PH-762 and plans an FDA meeting in Q3 2026 on next-phase clinical design.
Moderna Gains FDA Approval for MFLUSIVA, First mRNA Influenza Vaccine Cleared in the US
FDA clears Moderna's MFLUSIVA under BLA 125869/0, the first mRNA influenza vaccine approved in the US, indicated for adults 50 and older.
Onconetix Acquisition Target Realbotix Secures Streaming Series Appearance for Humanoid Robot
Realbotix, Onconetix's pending acquisition target, secures a streaming series deal as its humanoid robots expand across healthcare, education, and entertainment.
Lantheus Signs $8 Billion Merger with Curium to Build 70-Country Radiopharmaceutical Network
Lantheus and Curium announce an $8B merger creating a 70-country radiopharmaceutical network, with GMP and supply-chain implications across jurisdictions.
Worth your time this week
Roivant Targets September 2026 Brepocitinib Launch Following Dermatomyositis Commercial Preparations
Priovant Launches Phase 3 BEACON+ Trial of Brepocitinib in Cutaneous Sarcoidosis After FDA Breakthrough Designation
Harrow Acquires Global TYRVAYA Rights from Viatris, Including Pending MAAs Across Multiple Markets
