News
FDA Approves Zoryve for Psoriasis in Children Age 2+
4+ hour, 45+ min ago (447+ words) All Sci California-based Arcutis Biotherapeutics (Nasdaq: ARQT) has received US FDA approval to expand the indication for Zoryve (roflumilast) cream 0. 3% to children as young as age 2 with plaque psoriasis " making it the first once-daily, non-steroidal topical therapy approved for this…...
FDA Approves Casgevy Gene Therapy for Young Children
2+ hour, 37+ min ago (440+ words) All Sci The US FDA has supplementally approved Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent "-thalassemia (TDT) " marking the first gene therapy approved for young children…...
Pyxis Oncology Secures $114 M for MICVO Cancer Trial
23+ hour, 53+ min ago (611+ words) All Sci Boston-based Pyxis Oncology, Inc. (Nasdaq: PYXS) announced a private placement of up to USD 114 million to extend its cash runway into Q2 2027 and fund two imminent clinical data readouts for micvotabart pelidotin (MICVO), its lead antibody-drug conjugate (ADC), in…...
NCX 470 Advances to FDA Review for Glaucoma
1+ day, 2+ hour ago (609+ words) All Sci Kowa Company, Ltd. s submission of a New Drug Application (NDA) to the US FDA for NCX 470 (bimatoprost grenod), developed by France-based Nicox SA (Paris: COX), represents the second nitric oxide-donating prostaglandin analog to reach the FDA review…...
Vistagen's Fasedienol Fails Phase III Trial
1+ day, 5+ hour ago (835+ words) Vistagen's fasedienol fails second Phase III social anxiety trial, clouding acute treatment strategy All Sci Vistagen Therapeutics (Nasdaq: VTGN) reported that its PALISADE-4 Phase III trial of fasedienol for social anxiety disorder failed to meet its primary endpoint, delivering a…...
UCSF Develops Bispecific T Cell Engager for Solid Tumors
1+ day, 4+ hour ago (340+ words) All Sci University of California, San Francisco has received a USD 1. 64 million National Cancer Institute R01 award to develop a bispecific T cell engager (TCE) targeting ALPPL2, a cell surface antigen reported to have highly restricted expression in normal adult tissues while…...
Will Therapeutics Develops Drug for Anorexia Nervosa
1+ day, 20+ hour ago (443+ words) All Sci Montreal-based Will Therapeutics announced a government-backed research collaboration with the Douglas Hospital Research Centre to develop brain-penetrant small molecules targeting the neural circuitry of compulsive behavior, with anorexia nervosa as the lead indication. The project has received CAD…...
Xellar Raises $50 M Series A for Organ-on-Chip AI
1+ day, 20+ hour ago (286+ words) All Sci Boston-based Xellar Biosystems has closed a USD 50 million Series A and A+ financing round to advance its organ-on-chip-based drug discovery platform, which the company describes as a 3 D bio intelligence platform combining human tissue models, laboratory automation, and…...
Brukinsa Beats Chemotherapy in Mantle Cell Lymphoma
1+ day, 23+ hour ago (351+ words) All Sci Be One Medicines (Nasdaq: ONC) reported positive topline results from the Phase III MANGROVE trial showing that zanubrutinib (Brukinsa) plus rituximab reduced the risk of progression or death by 43% compared with bendamustine plus rituximab (BR) in previously untreated…...
FDA Pre Check Pilot Accelerates US Drug Manufacturing
1+ day, 23+ hour ago (377+ words) All Sci The FDA announced on June 29, 2026, the selection of seven companies to participate in its Pre Check Pilot Program, a two-phase initiative designed to accelerate regulatory readiness for new domestic pharmaceutical manufacturing facilities. The program was formally launched on…...