The U.S. Food and Drug Administration (FDA) today announced that it is initiating action to remove concentrated ingestible fluoride prescription drug products for children from the market. Unlike toothpaste with fluoride or fluoride rinses, these products are swallowed and ingested by infants and toddlers. They have also never been approved by the FDA. Ingested fluoride has been shown to alter the gut microbiome, which is of magnified concern given the early development of the gut microbiome in

May 19, 2025 -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the “Company” or “Appili”), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announced that Aditxt, Inc. (“NASDAQ:ADTX”) (“Aditxt”) has delivered notice (the “Termination Notice”) purporting to terminate the arrangement agreement dated April 1, 2024 between the Company, Aditxt, and its wholly-owned subsidiary, Adivir, Inc. (“Adivir”) (as amended on July 1, 2024 and f

JUV-161 is a first-in-class muscle regenerating biologic that will address myopathies starting with Myotonic Dystrophy Type 1 JUV-161 was discovered using Juvena’s proprietary JuvNET platform, an AI and stem cell secretome-based drug discovery and development platform May 19, 2025 -- Juvena Therapeutics, Inc. (“Juvena”), a clinical-stage biotechnology company pioneering tissue restorative biologics for chronic muscle and metabolic diseases, announced today that it is enrolling participants in

May 15, 2025 -- Pathos AI, a leading AI-driven biotech company applying cutting-edge artificial intelligence to drug development, today announced its $365 million Series D financing, bringing its post-money valuation to approximately $1.6 billion. This financing marks a major milestone for Pathos as it expands its AI-enabled platform to drive greater speed, precision, and success in oncology drug development. The proceeds will support advancement of the company’s clinical-stage pipeline and c

Despite growing recognition of long COVID as a serious condition, diagnosed patients have no approved treatment options, with many suffering from debilitating fatigue and brain fog Evidence suggests sustained inflammation plays a central role in the pathogenesis of long COVID, particularly in the associated cognitive dysfunction and other neurological symptoms1 Bezisterim targets key underlying mechanisms of neuroinflammation, and has demonstrated the potential to reduce chronic symptoms in Alzh

May 15, 2025 -- Axovia Therapeutics Ltd., a biotechnology company developing therapies to address the genetic causes of blindness and obesity, announced that today it will unveil new preclinical proof-of-concept data for novelly designed, AXV-201, to treat individuals with severe obesity and very high BMIs resulting from MC4R mutations, in a poster presentation at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, which is being held from May 13-17, 2025 in New Orleans,

Following the formal safety review of Cohort 1, no safety or tolerability issues were observed, allowing the company to move forward with Cohort 2. The company plans on releasing more detailed results from Phase 1 later in 2025 following completion of additional dose cohorts. May 19, 2025 -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell e

- First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) May 15, 2025 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the first pediatric AML patient has been dosed in the ongoing Phase 2 trial of SLS009 (ta

–FDA grants Priority Review of application, with PDUFA target action date of September 12, 2025– –ORLADEYO would be the first targeted oral prophylactic therapy for patients with HAE under the age of 12, if approved– May 14, 2025 -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for the use of oral, once-daily ORLADEYO® (berotralstat) in pediatric patients with hereditary angioedema (HA

May 14, 2025 -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB : BETRF / FRA: NPAU), an emerging biotech company focused on the development of BETR-001, a non-hallucinogenic neuroplastogen in the treatment of psychiatric and neurological disorders, recently presented a scientific update at Bloom Burton Conference on May 5, 2025 in Toronto, Canada. BetterLife reported that its proprietary compound, BETR-001, is showing very promising preclinical data of its breakthrou