March 10, 2026 -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to tegoprubart for the prevention of allograft rejection in liver transplantation. Tegoprubart has previously received orphan drug designation from the FDA for the prevention of allograft rejection in pancreatic islet cell transplantation and for the treatment of amyotrophic lateral sclerosis (ALS). “Clinical studies in kid

Phase I results demonstrate favorable safety, sustained target engagement, and early signs of anti-tumor activity Reinforce EP4 receptor antagonism as a validated, high-value strategy to overcome immunotherapy resistance March 10, 2026 -- Kainova Therapeutics (“the Company”), a key player for breakthrough treatments in immuno-oncology and inflammation, today announced positive topline results from its Phase I EPRAD study evaluating DT-9081, a proprietary, oral small molecule EP4 receptor (EP4R)

Niraparib and abiraterone acetate regimen demonstrates clinically meaningful delay in disease progression, nearly halving the risk of progression or death, with an early trend toward improved overall survival versus standard of care1 Approximately one in ten patients with mHSPC harbour BRCA1/2 alterations, reinforcing the need for new targeted treatment options2 Expanded indication for niraparib and abiraterone acetate delivers a precision-based treatment approach for this patient population

March 9, 2026 -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, and Kelun-Biotech (6990.HK) today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for HBM7575/SKB575, a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target co-developed by the

Potential best-in-class profile, including ~1,400-fold selective binding to MTA-PRMT5 versus SAM-PRMT5 complexes, and single-digit nanomolar potency in MTAP-deleted cell lines IDE892 is being evaluated as a monotherapy agent in MTAP-deleted solid tumors, including NSCLC and PDAC, and targeting combination FPI with IDE397 (MAT2A) in mid-2026 Targeting nomination of a first-in-class CDKN2A development candidate in H2 2026 and IND in H1 2027; prevalence of CDKN2A-deficiency has been reported at ove

March 9, 2026 -- Nanjing Leads Biolabs Co., Ltd. ("Leads Biolabs" or the "Company," Stock Code: 9887.HK) announced on March 6, 2026 that the first patient has been successfully dosed in a Phase Ⅱ clinical study evaluating Opamtistomig (LBL-024), the company's core investigational PD-L1/4-1BB bispecific antibody, for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). ESCC ranks as the seventh most common cancer in China, characterized by insidio

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