June 17, 2025 -- Medicovestor, Inc., a biotechnology company advancing next-generation antibody-drug conjugates (ADCs), announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ADoBind MC001, its lead candidate for the treatment of pancreatic cancer. Pancreatic cancer is among the most aggressive and fatal malignancies, with a five-year survival rate under 10% and limited treatment advances over the past decades. ADoBind MC001 is designed to

Two-part clinical study programme to evaluate change in lean and fat mass in patients receiving two different doses of S-pindolol benzoate whilst 1) receiving the GLP-1 agonist semaglutide; and 2) after cessation of semaglutide treatment Initial proof-of-concept data expected in second half of 2026 25 June 2025. Actimed Therapeutics Ltd (“Actimed”), a UK based clinical stage specialty pharmaceutical company focused on the treatment of cancer cachexia and other muscle wasting disorders, today an

Biodexa Pharmaceuticals PLC (“Biodexa” or “the Company”), (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, is pleased to announce the activation of the first clinical study site for its Serenta trial in patients with familial adenomatous polyposis (FAP). The trial, which is now enrolling, represents a significant milestone in the development of a potential new treatment option for FAP.

At the forefront of cancer treatment, scientists are continually exploring new targets and therapeutic strategies to address this global health challenge. B7-H3 (CD276), a type I transmembrane glycoprotein, has garnered significant attention due to its overexpression in a wide range of human cancers. Initially believed to function as a T-cell costimulatory molecule, B7-H3 has since been found to possess complex immunomodulatory properties, capable of both promoting and suppressing immune respons

The mRNA therapeutics market has experienced explosive growth over the past few years. According to estimates by QY Research, the global mRNA therapeutics market reached a total sales value of RMB 248.4 billion (approx. USD 35 billion) in 2023. Preventive mRNA vaccines are projected to achieve a 20% penetration rate in the USD 50.3 billion vaccine market by 2025, corresponding to a market size of USD 10.1 billion. Meanwhile, mRNA cancer vaccines are expected to reach a 0.5% penetration rate by 2

June 18, 2025 -- Diagonal Therapeutics, a biotechnology company focused on correcting dysregulated signaling with clustering antibodies that address the underlying cause of intractable genetic diseases, today announced that both the U.S. Food and Drug Administration (FDA) granted orphan drug designation (ODD) to DIAG723, a novel, bispecific antibody, for the treatment of hereditary hemorrhagic telangiectasia (HHT). Additionally, the European Medicines Agency (EMA) provided a positive opinio

- Based on Type C meeting and new data, Dyne submitted revised ACHIEVE trial protocol to FDA elevating vHOT to primary endpoint for U.S. Accelerated Approval - - New positive clinical data from Phase 1/2 ACHIEVE trial support vHOT as early indicator of clinical benefit with DYNE-101 in DM1 - - Ongoing Registrational Expansion Cohort in ACHIEVE trial to enroll 60 participants and include sites in U.S. - - Company to host an investor and analyst conference call today, June 17, at 8:00 a.m. ET - J

U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseases Capricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection June 17, 2025 -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today anno

June 15, 2025 Results from the EPCORE® NHL-2 trial show investigational treatment with epcoritamab in combination with rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) led to an overall response rate (ORR) of 87 percent and a complete response (CR) rate of 65 percent in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Data further demonstrates the potential of epcoritamab in combination with salvage chemoimmunotherapy to increase the proportion of patien

After a thorough clinical review, the benefit-risk for the use of Elevidys in non-ambulatory patients with Duchenne has been re-assessed, following two cases of fatal acute liver failure Effective immediately, dosing of non-ambulatory patients, irrespective of age, is paused in the clinical setting; dosing of non-ambulatory patients is discontinued in the commercial setting Roche is working closely with relevant health authorities, investigators and prescribing physicians to ensure they are info