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3230 News Found

AstraZeneca India receives permission from CDSCO for Datopotamab Deruxtecan powder
Drug Approval | December 18, 2025

AstraZeneca India receives permission from CDSCO for Datopotamab Deruxtecan powder

The receipt of this permission paves way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) in India


Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer
Clinical Trials | December 18, 2025

Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer

The combination also outperformed chemotherapy on another important secondary endpoint


Cynata completes patient enrollment for Phase 2 aGvHD clinical trial
Clinical Trials | December 17, 2025

Cynata completes patient enrollment for Phase 2 aGvHD clinical trial

Patient enrolment has been completed in Cynata's Phase 2 clinical trial of CYP-001 in acute graft versus host disease


AstraZeneca wins EU nod for self-administered lupus drug Saphnelo
News | December 17, 2025

AstraZeneca wins EU nod for self-administered lupus drug Saphnelo

Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion


Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug
Drug Approval | December 17, 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients


FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


FDA nod to first oral single-dose treatment for gonorrhea
Drug Approval | December 16, 2025

FDA nod to first oral single-dose treatment for gonorrhea

The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership


Pharma overhaul: EMA hails “Once-in-a-Generation” reform
Policy | December 16, 2025

Pharma overhaul: EMA hails “Once-in-a-Generation” reform

The reform is set to modernise how medicines are developed, authorised, and made available across the EU