Acurx is launching a ground-breaking clinical trial with ibezapolstat in patients with multiply-recurrent CDI (rCDI) that has the potential to shift the paradigm of treatment and prevention of rCDI from two agents to one When coupled with IBZ Phase 2 results of being highly effective (96% clinical cure of 26 patients) in treating acute CDI with no recurrence in patients while sparing the gut microbiome, this new trial will position IBZ as a candidate to be the first agent to demonstrate clinical

Approval based on unprecedented Phase 3 data demonstrating statistically significant improvements in progression–free survival and overall survival versus standard of care regimens 83.3% of patients were alive at three years, indicating durable clinical benefit March 5, 2026 -- Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab a

March 5, 2026 -- Hemab Therapeutics, a late stage clinical biotechnology company developing novel prophylactic therapeutics for serious, underserved coagulation disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for sutacimig for the prevention of bleeding episodes in patients with Glanzmann thrombasthenia (GT). "We are proud to announce this Breakthrough Therapy Designation, which recognizes both the potential for suta

FDA assigns PDUFA target action date in the third quarter of calendar year 2026 with launch expected at the end of September 2026 Priority Review supported by positive Phase 3 VALOR results, the first positive 52-week placebo-controlled trial in dermatomyositis If approved, brepocitinib would represent the first targeted therapy approved for dermatomyositis March 03, 2026 -- Priovant Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Applic

An investigational medicine that addresses the genetic root cause of BAG3 DCM, AFTX-201 is being evaluated in the UPBEAT© clinical trial AFTX-201 is designed using Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies

Substantial clinical evidence provides rationale to initiate Phase 2 study in PV Phase 2 study expected to begin 3Q26 with potential for data readouts as early as 4Q26 and throughout 2027 AN2 to host webcast on Wednesday, March 4, 2026 at 9:30am ET/ 6:30am PT AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today announced its plans to expand the development of oral epetrabor

Syntis Bio, Inc. a clinical-stage biopharmaceutical company advancing novel oral therapeutics that uniquely leverage the small intestine, today announced that the first patient has been dosed in the Phase 1/1b SYNTIETY-1 clinical trial of SYNT-101, the company’s lead investigational program for the treatment of obesity. SYNT-101 is designed as a once-daily oral pill that redirects nutrient absorption past the small intestine’s duodenum, mimicking the effects of gastric bypass surgery. "Dosing o

March 3, 2026 -- On March 2, 2026, Pierre Fabre Pharmaceuticals, Inc., submitted a request to the U.S. Food and Drug Administration (FDA) for a Type A meeting on the biologic license application for tabelecleucel, an allogeneic T-cell therapy with a proposed indication for relapsed/refractory Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease (EBV+ PTLD), to address the January 9, 2026 Complete Response Letter from the agency. "We look forward to meeting with the agency to

Low dose alnodesertib plus gemcitabine met the primary endpoint of progression-free survival (PFS) versus gemcitabine alone in patients with platinum-resistant high-grade serous ovarian cancer Study provides additional proof of concept that combining alnodesertib with DNA-damaging agents in high replication stress cancers delays tumor progression Phase 2 studies with higher dose alnodesertib plus irinotecan are ongoing in ATM-negative colorectal and pancreatic cancers March 2, 2026 – Artios P

225 Ac-PSMA-Trillium (BAY 3563254) is an investigational targeted alpha therapy (TAT) being developed for patients with advanced metastatic castration-resistant prostate cancer (mCRPC) Data from PAnTHa, the global Phase I first-in-human, dose-escalation study were presented during the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco, CA Data support advancing 225Ac-PSMA-Trillium to the next phase of development Prostate cancer is the second most common