Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubled progression-free survival in the first-line setting1 The Itovebi-based regimen also demonstrated a statistically significant and clinically meaningful benefit in overall survival (OS) in the final OS analysis Final OS data will be presented in an oral session at the 2025 American Society of Clinical Oncology Annual Meeting 23 May 2025 - Roche

• Significantly expands IB-Stim’s total addressable market • Clearance covers patients aged 8–21 • Seamless go-to-market strategy with existing reimbursement and provider infrastructure May 20, 2025 -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies addressing chronic and debilitating conditions in children and adults, today announced that it has received FDA 510(k) clearance for IB-Stim™ for the

Positive results show that a single dose of BPL-003, administered adjunctively to SSRIs, produced a rapid and long-lasting antidepressant effect for up to three months after dosing. BPL-003 was well-tolerated and patients were able to be discharged within an average time of less than two hours. Data from the core, randomised stage of Beckley Psytech’s Phase IIb study of BPL-003 for treatment resistant depression is expected in mid-2025. 20 MAY 2025. Beckley Psytech Ltd, a private clinical-stage

The program, licensed exclusively to BMS, represents the third ADC candidate using the company’s proprietary Tubutecan technology to reach the clinic. May 20, 2025 – Tubulis today announced that the first program from its strategic license agreement with Bristol Myers Squibb has entered clinical development, triggering a significant milestone in the ongoing collaboration to develop next generation antibody drug candidates (ADCs) for the treatment of cancer. The agreement, signed in 2023, was es

These results indicate that EXACT Therapeutics’ Acoustic Cluster Therapy (ACT®) significantly enhances the local effect of chemotherapy In the patients who had a response to chemotherapy, ACT-treated tumours showed a significantly greater reduction in diameter compared to control tumours (-29% vs. -7%, pFinal analysis mirrors the excellent safety profile of PS101 seen in the interim read-out and suggests a dose-response relationship The data supports the company’s plans for its Phase 2 trial (EN

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 6, 2025 – Today, CityHealth, an initiative of the de Beaumont Foundation and Kaiser Permanente, awarded the City of Omaha its first overall bronze medal — recognizing the city’s leadership for advancing six high-quality policies that support the health and well-being of its residents. The announcement was made at today’s city council meeting, where councilmembers accepted the overall bronze medal and celebrated this significant milestone. In 2024, Omaha was the only city in the nation to ear

--- Ruxoprubart (NM8074) met all clinical endpoints, offering a safe, differentiated treatment for Paroxysmal Nocturnal Hemoglobinuria (PNH). Paroxysmal Nocturnal Hemoglobinuria (PNH) is a rare hematological (Blood) disorder. Regulatory approval for the Phase II trial in PNH subjects was granted based on the safety profile of healthy subjects in the Phase I trial. Interim results from this 12-subject, three-month, multi-dose Phase II efficacy trial are compelling. The drug was safe and well-to

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

Preconditioning with lymphodepletion linked to stronger MAR-T cells response and suggests enhanced anti-tumor activity Highest enrollment since study launch underscores momentum and signals a positive trial trajectory Clinical data readout from Phase 1 APOLLO study expected later this year May 20, 2025 (GLOBE NEWSWIRE) -- Marker Therapeutics, Inc. (Nasdaq: MRKR), a clinical-stage immuno-oncology company focusing on developing next-generation T cell-based immunotherapies for the treatment of h