The US Food and Drug Administration (FDA) has granted priority review designation for the new drug application for tinlarebant (LBS-008; Belite Bio) for the treatment of Stargardt Disease Type 1 (STGD1). The FDA has set a Prescription Drug User Fee Act date of February 12, 2027. According to the company, the filing was based on the results from the phase 3 DRAGON trial, which evaluated tinlarebant for the treatment of STGD1. In the study, tinlarebant demonstrated a statistically significant and

VEPPANU is the first and only FDA-approved PROTAC and has the potential to become an important new treatment option for adult patients with 2L+ ER+/HER2-, ESR1-mutated mBC Aug. 11, 2026 -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced VEPPANU (vepdegestrant) is now available by prescription in the United States for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal grow

- All 56 planned participants enrolled approximately five months after first patient dosing - Topline Phase 2 data expected in late 2026 - Positive data could support expansion of CNT201 into Peyronie's disease and cellulite Aug. 17, 2026 -- Connext, a specialty therapeutics company focused on developing innovative therapies for significant unmet medical needs, today announced that it has completed enrollment in the Phase 2 portion of its ongoing Phase 1/2 clinical trial evaluating CNT201 for t

Aug. 17, 2026 -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution. UGN-103 is a next-generation mitomycin formulation being developed for the treatment of adults with recurrent low-grade intermediate-r

Shortly after inking a deal to expand its rights to CD38-targeting antibody felzartamab across the globe, Biogen has won approval for the drug's use to treat multiple myeloma (MM) in China. China's National Medical Products Administration (NMPA) on Thursday approved felzartamab in combination with lenalidomide and dexamethasone to treat adults with MM who have received at least one prior line of therapy, according to a report from China Daily. Biogen initially gained ex-China global rights to

Tissue analysis showed significantly higher numbers of myelin-positive cells in ExoPTEN-treated animals compared with controls, providing additional preclinical biological support for previously reported functional recovery Aug. 14, 2026 -- NurExone Biologic Inc. ("NurExone" or the "Company") (TSXV: NRX, OTCQB: NRXBF, FSE: J90), a biotechnology company developing exosome-based regenerative therapies, today announced new preclinical tissue-analysis results that provide additional biological supp

Approval based on EXCALIBER-RRMM results showing ZDd doubled minimal residual disease-negative complete response rates versus daratumumab, bortezomib and dexamethasone (41% vs. 21%) in relapsed or refractory multiple myeloma(1) ZENBEXUS marks the arrival of a new treatment class, representing the next chapter in Bristol Myers Squibb’s targeted protein degradation platform PRINCETON, N.J.---Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has appr

Aug. 10, 2026 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that the first patient has been dosed in a Phase II clinical study (AK146D1-202) evaluating AK146D1, the Company's internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (bsADC), in combination with ivonescimab (the Company's PD-1/VEGF bispecific antibody), for the treatment of advanced breast cancer. This study aims to explore the potential of Akeso's "IO2.0 + ADC2.0" regimen in advanced breast cancer,

Orion’s license partner Tenax Therapeutics’ Phase 3 LEVEL trial of oral levosimendan in pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint Orion Corporation’s license partner Tenax Therapeutics, Inc., today announced that the Phase 3 LEVEL clinical trial evaluating oral levosimendan in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF) did not reach its primary endpoint of

Spevatamig is Phanes' anti-CLDN18.2/CD47 bispecific antibody that functions as an innate immunity enhancer (I2E), an emerging class of immuno-oncology (IO) agents. Spevatamig is currently in Phase 2 studies for the treatment of multiple forms of gastrointestinal cancers. This designation highlights the unmet need for novel treatments for patients living with biliary tract cancer (BTC) and the potential of spevatamig for this indication. Aug. 14, 2026 -- Phanes Therapeutics, Inc. (Phanes), a cli