Fast Track Designation

UCB announces FDA approval of ZILBRYSQ for the Treatment of Adults with Generalized Myasthenia Gravis On the 17th of October 2023, UCB (Euronext Brussels: UCB) made an announcement regarding the approval of ZILBRYSQ® (zilucoplan) by the US FDA for the management of generalized myasthenia gravis (gMG) in adult pa...

South Rampart Pharma Receives U.S. FDA Fast Track Designation for SRP-001 for Acute Pain On October 12, 2023, South Rampart Pharma, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Fast Track status to its drug candidate, SRP-001, intended for the management of acute pain. SRP-001 is a...

AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone ...

EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...

FDA Grants Breakthrough Therapy Designations to Trastuzumab Deruxtecan for HER2+ Solid Tumors, Including mCRC ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted two additional Breakthrough Therapy Designations (BTDs) in the United States for the treatment of adult patients with unresectable or metastati...

FDA Approves Bristol Myers Squibb’s Reblozyl as First-Line Treatment of Anemia in Adults with Lower-Risk MDS Who May Require Transfusions Bristol Myers Squibb announced that the Food and Drug Administration (FDA) has approved Reblozyl® (luspatercept-aamt) for the treatment of anemia in adult patients with very l...

FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...

Gilead To Discontinue Phase III ENHANCE Study of Magrolimab Plus Azacitidine in Higher-Risk MDS Gilead Sciences, Inc. reported that the Phase III ENHANCE study in higher-risk myelodysplastic syndromes (MDS) has been halted due to futility based on a planned analysis. The safety data in this trial are consistent ...

Lilly to Acquire Versanis to Improve Patient Outcomes in Cardiometabolic Diseases Eli Lilly & Company and Versanis Bio announced a definitive agreement for Lilly to acquire Versanis, a private clinical-stage biopharmaceutical firm focused on the discovery of novel medications for the treatment of cardiometab...

FDA Approves First Gene Therapy for Severe Hemophilia A BioMarin Pharmaceutical Inc., a global biotechnology company dedicated to transforming lives through genetic discovery, announced that the US Food and Drug Administration (FDA) has approved ROCTAVIAN (valoctocogene roxaparvovec-rvox) gene therapy for the tr...