FibroGen has reached agreement with the FDA on important design elements for a pivotal Phase 3 clinical trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden Company intends to file the Phase 3 protocol in the fourth quarter of 2025 Aug. 07, 2025 -- FibroGen, Inc. (NASDAQ: FGEN) today announced positive feedback from its Type C meeting with the FDA, supporting the advancement of roxadusta

CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by CAINS-MAP. CT-155 is an investigational prescription digital therapeutic being evaluated to target negative symptoms of schizophrenia in a registrational randomized clinical trial.1,2 Often underappreciated and less recognized, negative symptoms impact more than half of people living with schizophrenia.3 Boehringer Ingelheim and Click Thera

FDA-approved protocol update significantly expands patient eligibility criteria for the BACKBEAT global pivotal study (“BACKBEAT study”), resulting in an estimated more than 24-fold increase in the potentially eligible patient pool as compared to original study protocol Expanded eligibility criteria now include screening of any hypertensive patients who have received or are scheduled to receive a Medtronic Azure™ or Astra™ pacemaker, including device replacements Aug. 08, 2025 -- Orchestra Bi

- ProLectin-M is currently being developed under an active Investigational New Drug (IND) application with the FDA Aug. 07, 2025 -- BIOXYTRAN, INC. (OTCQB: BIXT) (the “Company”), a clinical stage biotechnology company pioneering innovative therapies for viral diseases, is pleased to announce significant progress in development of its broad-spectrum antiviral drug, ProLectin-M. The company has successfully completed dosing of its dose optimization clinical trial, bringing it one step closer to

Aug. 08, 2025 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application (“sNDA”) for toripalimab (trade name: TUOYI®) in combination with disitamab vedotin, an antibody-drug conjugate (“ADC”) developed by RemeGen Co., Ltd. as the treatment of HER2-expressing (HER2 expression is

Annovis achieves comprehensive intellectual property (IP) protection now covering both the original semi-crystalline and new crystalline forms of buntanetap. Both forms are covered by a total of 13 patent families. All patents are filed internationally, securing global coverage of buntanetap. Aug. 07, 2025-- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheim

Aug. 07, 2025 -- SNIPR Biome ApS (“SNIPR”), the company pioneering the development of microbial CRISPR-medicine, today announced the close of a EUR 35 million Series B raise with funding from new investors the Cystic Fibrosis Foundation and the German Federal Agency for Breakthrough Innovation (SPRIN-D) as well as existing investors Lundbeckfonden BioCapital, North-East Family Office and Wellington Partners. This funding will support the development of a CRISPR-Cas therapy specifically target

Gildeuretinol acetate demonstrated less loss in ellipsoid zone (EZ) area compared to historical sibling controls. Early-stage Stargardt disease patients treated with gildeuretinol for two to seven years exhibited relatively stable disease over the course therapy. Gildeuretinol was well tolerated and had a safety profile consistent with prior gildeuretinol studies, with the majority of adverse events being mild or moderate. Aug. 07, 2025 -- Alkeus Pharmaceuticals, Inc. today announced the pres

‘1104 sublingual formulation achieved extensive systemic exposure and demonstrated impact across measures of disease in additional preclinical studies in atopic dermatitis Sublingual formulation and novel upstream mechanism of action for ‘1104, supported in Phase 2 trials with IV formulation, offers differentiated product profile and expanding target patient market in eosinophilic esophagitis (EoE), atopic dermatitis (AD) and other allergic disease patients Sublingual formulation expected to ent

First patient successfully completes dosing at Toronto General Hospital St. Michael’s Hospital is expected to be the next Canadian clinical site activated Arch is looking for additional clinical sites in North America to join the trial Aug. 06, 2025 -- Arch Biopartners Inc. (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF) announced today that the first patient has successfully completed dosing at Toronto General Hospital (TGH), part of the University Health Network (UHN), Canada’