New Drug Application for azetukalner in focal seizures submitted to U.S. Food and Drug Administration; X-TOLE3 and X-ACKT continue to enroll focal seizure and PGTCS patients, respectively Enrollment in X-NOVA2 study in MDD completed with approximately 360 total patients; topline data readout expected Q1 2027 The Company has voluntarily initiated a temporary pause of enrollment of new patients in ongoing psychiatry studies; patients currently enrolled in the ongoing studies remain active Confer

Protocol Submitted for IRB Review at a Leading Cancer Research Institution, Advancing the Study Toward Site Initiation Sept. 17, 2026 -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced that, following review and comments from the U.S. Food and Drug Administration (FDA), the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has

Novartis receives positive CHMP opinion for Cosentyx® in polymyalgia rheumatica (PMR) If approved, Cosentyx (secukinumab) will be first IL-17A inhibitor licensed in Europe for adults with polymyalgia rheumatica (PMR), providing new treatment option after steroids¹ Recommendation based on data showing Cosentyx doubled sustained remission rates and delivered steroid sparing effects vs placebo; safety was consistent with established Cosentyx profile² Despite being a common inflammatory rheumatic di

Silo Pharma Receives U.S. Patent Allowance for SPC-15 PTSD Treatment, Expanding Intellectual Property Portfolio Allowed claims cover compositions and methods for preventing or mitigating stress-induced behavioral responses Sept. 18, 2026 -- Silo Pharma (Nasdaq: SILO) (“Silo” or “the Company”), a developmental-stage biopharmaceutical company focused on novel therapeutics and drug delivery systems with a wholly owned managed AI agent platform, today announced that the United States Patent and Tr

FAYUVI is a highly anticipated, first-ever treatment option with the potential to stop or slow the devastating, irreversible neurologic progression and loss of function associated with Sanfilippo syndrome Type A Ultragenyx’s UltraCare® program will support access, and commercial product is expected to be available to ship to Qualified Treatment Centers within 30-60 days FAYUVI marks the second gene therapy approval, and sixth FDA approval overall, for Ultragenyx The Company received a Priority

Results from the POETYK PsA-2 open-label extension demonstrated robust response rates in patients treated with Sotyktu, with clinical responses continuing to improve through year one and maintained through year two Two-year data build on the proven efficacy and safety pro Sotyktu as the only approved tyrosine kinase 2 (TYK2) inhibitor for adults with psoriatic arthritis Bristol Myers Squibb (NYSE: BMY) today announced positive results through two years of treatment from the Phase 3 POETYK PsA-

FRONTIER5 data show investigational denecimig was well-tolerated with no unforeseen safety concerns after a direct switch from emicizumab, without the need for a washout period or loading dose, in people with hemophilia A aged 12 and older with or without inhibitors1 Most patients reported the denecimig pen injector easy to use compared to their previous emicizumab vial and syringe system, as measured by a device questionnaire1 Denecimig increased thrombin generation, a measure of blood clotting

The top line results showed that the ELPIS II trial did not meet its primary endpoint of improvement in right ventricular ejection fraction (RVEF) at month 12, but there were exploratory clinical endpoints that the Company is continuing to analyze and plans to discuss with the FDA to determine a potential path forward in HLHS Laromestrocel has maintained what Longeveron believes is a favorable safety and tolerability pro with prior clinical trials, now with 644 patients treated across Longeveron

Sept. 17, 2026 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that AK158D1, its investigational next-generation bispecific antibody-drug conjugate (ADC) targeting EGFR and TROP2, has secured Phase I clinical trial clearance from the Center for Drug Evaluation (CDE) under China's National Medical Products Administration (NMPA). The trial will assess the candidate in patients with advanced malignant solid tumors. AK158D1 is Akeso's fourth ADC to enter clinical development and joins

Sept. 16, 2026 -- Prescription-only treatment gives clinicians a new way to treat eligible adults with moderate to severe major depressive disorder at home, either as a standalone treatment or alongside medication Flow Neuroscience today announced that FL-100 is now available by prescription across the United States, introducing the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression to the US market. FL-100 is intended for the treatment of modera