GSK’s Rare Blood Cancer Candidate Goes Under FDA Review
The FDA has accepted GSK plc’s (NYSE:GSK) marketing application for momelotinib, a potential new medicine with a proposed differentiated mechanism of…
Omeros Corporation Receives Interim Response From FDA On Formal Dispute Resolution Request For Narsoplimab
Omeros Corporation (NASDAQ:OMER) today announced that the United States Food and Drug Administration (FDA) provided an interim response to the company’s formal dispute resolution request submitted to the Agency in
Enlivex Receives Israeli Ministry Of Health Approval For The Initiation Of A Phase I/II Trial Evaluating Allocetra Alone And In Combination With A PD1 Checkpoint Inhibitor In Patients With Advanced Solid Tumors
Trial builds on encouraging preclinical studies conducted in collaboration with Yale Cancer Center that showed a substantial, statistically significant survival benefit when Allocetra™ was combined with PD1
RedHill Biopharma Announces EU Orphan Drug Designation For RHB-204 For NTM Infections
Developed as the first stand-alone standard of care first-line therapy for NTM disease caused by Mycobacterium avium complex (MAC) infection, RHB-204 is currently undergoing a Phase 3 study in the U.S.
EMA Orphan Drug
Arrowhead Files For Regulatory Clearance To Initiate Phase 1/2a Study Of ARO-MMP7 For Idiopathic Pulmonary Fibrosis
Arrowhead Pharmaceuticals Inc. (NASDAQ:ARWR) today announced that it has filed an application for clearance to initiate a Phase 1/2a clinical trial of ARO-MMP7, the company's investigational RNA interference (RNAi)
Can-Fite Announces Piclidenoson Is Set To Enter Clinical Trial For Treatment Of Osteoarthritis In Dogs Efficacy Trial To Commence And Financially Covered By Vetbiolix
Safety study successfully completed; efficacy trial to commence and financially covered by Vetbiolix
Canine osteoarthritis market is projected to reach $3 billion by 2028
PETACH TIKVA, Israel--(BUSINESS WIRE)--
GSK Announced FDA Accepted New Drug Application for Momelotinib for the Treatment of Myelofibrosis
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for momelotinib, a potential new medicine with a proposed differentiated mechanism of action that may address the significant unmet medical needs of myelofibrosis patients with anaemia. The US FDA has assigned a Prescription Drug User Fee Act action date of 16 June 2023.
Recap Of Tuesday’s Biotech Catalysts – End Of the Day Summary
The U.S. Food and Drug Administration (FDA) has approved Amphastar’s (NASDAQ:AMPH) New Drug Application (ND”) for Epinephrine injection…
ICL And Lavie Bio Enter Collaboration To Develop Novel Bio-Stimulant Products; ICL To Invest $10M In Lavie Bio
ICL to invest $10 million in Lavie Bio
ICL (NYSE:ICL) (TASE: ICL), a leading global specialty minerals company, and Evogene Ltd. (NASDAQ:EVGN) (TASE: EVGN), a leading computational biology company focused
I-Mab And AbbVie Entered Amendment To Original License And Collaboration Agreement; Parties Will Continue To Collaborate On Anti-CD47 Antibody Program, I-Mab Eligible to Receive Up To $1.295B Milestones
I-Mab (the “Company”) (NASDAQ:IMAB) today announced that the Company and AbbVie Global Enterprises Ltd. (as assignee of AbbVie Ireland Unlimited Company) (“AbbVie”) have entered into an amendment