FDA Approves Jazz Pharma’s Zepzelca + Tecentriq Combo for ES-SCLC
DUBLIN, Oct. 2, 2025 – Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration...
Oncology
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FDA Grants Orphan Drug Status to Aminex’s AMXT 1501-DFMO Combo
SEATTLE — October 2, 2025 — Aminex Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel therapies for...
AbbVie Submits BLA for Pivekimab Sunirine to FDA for Rare Blood Cancer
North Chicago, IL – September 30, 2025 – AbbVie (NYSE: ABBV) announced the submission of a Biologics License Application...
FDA Approves Eli Lilly’s Inluriyo for ESR1-Mutated Breast Cancer
Indianapolis, Sept. 25, 2025 – In a landmark advancement for breast cancer treatment, the U.S. Food and Drug Administration...
UK Approves Avantect Multi-Cancer and Ovarian Tests
SAN DIEGO, Sept. 25, 2025 — ClearNote Health announced that it has received UK Conformity Assessed (UKCA) approval for...
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Bristol Myers Squibb’s Iberdomide Shows Strong Phase 3 Results in Multiple Myeloma
Princeton, N.J., September 22, 2025 – Bristol Myers Squibb (BMS) announced that its investigational cereblon E3 ligase modulator (CELMoD™)...
Tezspire Wins CHMP Backing for Chronic Rhinosinusitis in EU
September 22, 2025 – Brussels, Belgium – AstraZeneca and Amgen announced that the European Medicines Agency’s (EMA) Committee for...
SystImmune Showcases Pivotal ADC Data at ESMO 2025, Strengthening Next-Generation Cancer Pipeline
REDMOND, Wash., Sept. 24, 2025 – SystImmune, Inc. announced the upcoming presentation of new clinical data on izalontamab brengitecan...
EU Approves ROMVIMZA™, First Therapy for TGCT Patients in Europe
Brussels, Belgium – September 17, 2025 – In a landmark development for rare disease patients, the European Commission (EC)...
Daiichi Sankyo and Merck Strengthen ADC Pipeline with FDA Nod
BASKING RIDGE, N.J. and RAHWAY, N.J., September 15, 2025 – Daiichi Sankyo and Merck (known as MSD outside the...
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