FDA approves Novartis radioligand therapy Pluvicto for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer
Ad hoc announcement pursuant to Art. 53 LR New indication approximately triples…
Pleco Therapeutics Announces Positive Outcome of Pre-IND meeting with FDA for PTX-252 in Acute Myeloid Leukaemia
NIJMEGEN, The Netherlands, March 26, 2025 (GLOBE NEWSWIRE) -- Pleco Therapeutics, a…
FDA Issues Nyxoah an Approvable Letter for its Genio System
INSIDE INFORMATIONREGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio®…
Press Release: Chlamydia vaccine candidate granted fast track designation by the US FDA
Chlamydia vaccine candidate granted fast track designation by the US FDA Chlamydia…
Novartis receives third FDA approval for oral Fabhalta (iptacopan) the first and only treatment approved in C3 glomerulopathy (C3G)
Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first…
Bavarian Nordic Receives U.S. FDA Approval of Chikungunya Vaccine for Persons Aged 12 and Older
First chikungunya vaccine approved for persons as young as 12 years old,…
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
– GOMEKLI is the first and only medicine approved for both adults…
SpringWorks Therapeutics Announces FDA Approval of GOMEKLI (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
– GOMEKLI is the first and only medicine approved for both adults…
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
As seen in the DESTINY-Breast06 trial, approximately 20-25 percent of hormone receptor…
FDA Authorizes All ZYN Nicotine Pouch Products Currently Marketed by Swedish Match in the U.S.
FDA decision makes ZYN the first authorized nicotine pouch productScience-based decision affirms…
