-Thubrikar Aortic Valve, Inc. announced its partnership with MAC’s MEDICAL Group, a distributor of cardiovascular devices in Europe, and MAC&...
If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults wit...
Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model — from drug rep...
Recommendation follows an Article 20 non-pharmacovigilance procedure Patients currently on TAVNEOS treatment should consult their treating physi...
The positive opinion is based on results from the Phase 3 BRUIN CLL-313 and BRUIN CLL-314 trials, previously presented at the 2025 American Society of He...
First and only CDK4/6 inhibitor approved for HR+ metastatic disease regardless of HER2 status Approval based on data from the collaborative Phase 3 ...
Pathway Labs announced its public launch of EchoNext, the world’s first FDA-approved AI detection tool that reads standard 12-lead electrocard...
First PMDA-approved molecular residual disease (MRD) test in Japan, supporting the use of Signatera in the adjuvant setting Commercial launch ex...
First regulatory approval for iza-bren (BL-B01D1), a first-in-class EGFR×HER3 bispecific antibody-drug conjugate (ADC) Represents an important n...
Wayrilz is a BTK inhibitor that works through multi-immune modulation to help address the underlying causes of immune thrombocytopenia (ITP) Approval ...
Contamination control is no longer viewed solely through the lens of compliance. Across today's biopharmaceutical manufacturing landscape, it has become a ...
NDA submission supported by positive Phase 3 data recently published in JAMA Neurology. Ecopipam is a first-in-class selective dopamine D1 receptor an...
Biogen Inc. (Nasdaq: BIIB) and RayThera Inc., a private biotechnology company focused on discovering and developing small molecule therapies in immunolog...
Filing acceptance based on data from the phase III SUNMO study where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of dis...
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