The FDA has approved Merck KGaA's oral CSF-1R inhibitor Pimjetmi (pimicotinib) for adults with symptomatic tenosynovial giant cell tumour (TGCT) for whom surgical removal could cause worsening functional limitations or severe morbidity. The decision gives the German drugmaker another major market for the treatment, following approvals in China, Canada and Switzerland. TGCT is a rare, usually benign tumour arising from the synovium of joints, tendon sheaths and bursae. While it doesn't typically

Trial designed to improve outcomes through Signatera™-guided Treatment on MRD (TOMR), identifying high-risk patients for curative-intent treatment Natera, Inc. (Nasdaq:NTRA), a global leader in cell-free DNA and precision medicine, today announced that it has entered into a clinical collaboration agreement with Incyte (Nasdaq:INCY) for a new phase II study in colorectal cancer (CRC). The trial will evaluate INCA33890, Incyte’s investigational bispecific immunotherapy, in patients with stage 2/

Breakthrough Therapy designation granted based on FDA’s review of safety and efficacy data from the chronic cohort of the Phase 1b/2a CONNECT SCI study Phase 3 RESTORE registrational study enrolling participants, with site activation continuing in the United States and Canada Nov. 12, 2026 -- NervGen (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic condition

Financing will support Phase II development of Zalsupindole on the back of strong Phase Ib results Funding will also further advancement of other programs in Delix’s neuroplastogen pipeline, including additional clinical trials and continued asset-specific pipeline expansion into neurological and neurodegenerative diseases Representatives of both lead investors will join Delix’s Board of Directors Delix Therapeutics, a clinical-stage neuroscience company pioneering the discovery and development

Following a crushing Phase III defeat in atrial fibrillation (AF) three years ago, Bayer's asundexian has now become the first approved factor XIa inhibitor in the US following an FDA nod Monday in secondary stroke prevention. The once-daily oral drug, which will be sold as Sunharbo, is indicated for use in combination with antiplatelet therapy to reduce the risk of stroke in adults with recent non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack (TIA). "This FDA approval r

FDA feedback supports planned bioequivalence-based 505(b)(2) development pathway for once-daily treprostinil prodrug patch Corsair Pharma, Inc., a private, clinical-stage biopharmaceutical company developing prodrug-based transdermal medicines to improve the delivery and therapeutic pro established therapies, today announced a positive outcome from its pre-investigational new drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) for the TRX-248 Transdermal System, a treprostin

Encouraging safety and pharmacodynamic activity observed with HB2198 in normal healthy volunteers was presented with additional preclinical data at the American College of Rheumatology (ACR) Convergence 2026 Nov. 09, 2026 -- Hinge Bio, Inc., a privately-held clinical-stage biotechnology company focused on the discovery and development of best-in-class antibody therapeutics, referred to as “GEM-DIMERs TM”, today provided clinical and additional preclinical data on HB2198 at the American College o

Efinopegdutide demonstrated a statistically significant greater proportion of participants achieved MASH resolution without worsening of fibrosis versus placebo at 52 weeks Meaningful improvements were observed in liver fibrosis without worsening of steatohepatitis, a key secondary histologic endpoint Results presented at The Liver Meeting® and published in The Lancet Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of positive results fr

If approved, cebranopadol would be the first dual NOP/MOP receptor (dual-NMR) agonist analgesic available for moderate-to-severe acute pain, introducing a novel mechanism of action to a treatment landscape in need of additional therapeutic options NDA submission is backed by positive results from the pivotal Phase 3 ALLEVIATE-1 and ALLEVIATE-2 studies, which met their primary efficacy endpoints and demonstrated cebranopadol’s potential to significantly reduce moderate-to-severe acute pain across

Boehringer Ingelheim's survodutide is the first glucagon/GLP-1 dual agonist to demonstrate a favorable cardiovascular safety profile in global Phase III SYNCHRONIZE-CVOT trial alongside significant cardiometabolic benefits SYNCHRONIZE-CVOT met its primary endpoint demonstrating the safety of survodutide in terms of major adverse cardiovascular events compared with placebo in people with obesity and established cardiovascular disease (CVD), chronic kidney disease, and/or at least two weight-relat