U.S. Food and Drug Administration approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those th...
Novartis is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Fabhalta® (iptacopan), a ground...
Thermo Fisher Scientific Inc., the world leader in serving science, announced that its SeCore™ CDx HLA A Sequencing System has been granted 5...
Agilent that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovia...
Approved for advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy TECELRA is the first new treatment ...
FDA grants priority review and assigns a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025 – – Suzetrigine...
Varian, a Siemens Healthineers company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new functionality to its ...
Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) s...
Senhwa Biosciences, Inc. (TPEx: 6492), announced IND Submission to US FDA for the Phase I/II study of Silmitasertib (CX-4945) in combination with c...
Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 – - EU Marketing Authorizat...
Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk...
Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA&re...
SCG Cell Therapy Pte Ltd (SCG), a biotechnology company developing novel immunotherapies for infectious diseases and their associated cancers, today anno...
Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical Laboratory Improvement Amendments (CLIA) Waiver approval for ...
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