BioRestorative Announces FDA Clearance of IND for Phase 2 Trial of BRTX-100 in Chronic Cervical Discogenic Pain
– BRTX-100 is the first and only stem cell product candidate cleared…
United States FDA Approves NM8074 (Ruxoprubart) IND for Treating Dermatomyositis (DM): A Chronic Inflammatory Disorder of the Skin
--- The United States FDA Approves the Initiation for Phase II Efficacy…
FDA Approves Samsung Bioepis OSPOMYV, XBRYK (denosumab-dssb), a Biosimilar to Prolia and Xgeva
OSPOMYV™ and XBRYK™ approved by the U.S. Food and Drug Administration (FDA)…
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,…
Ibex Medical Analytics Receives First FDA 510(k) Clearance
FDA clearance affirms Ibex’s position as a global leader in AI-powered cancer…
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…
FDA Authorizes Myocene Device for Muscle Fatigue Monitoring and Informed Training Decisions
LIÈGE, Belgium, Jan. 27, 2025 (GLOBE NEWSWIRE) -- Myocene, the Belgian sportstech…
MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function
Transdermal GFR System (TGFR) is a first-in-kind product for point of care…
MediBeacon Transdermal GFR System Receives FDA Approval to Assess Kidney Function
Transdermal GFR System (TGFR) is a first-in-kind product for point of care…