IND submission marks Matter Bio's transition toward clinical stage and advances its lead Listeria-based immunotherapy into one of oncology's highest-need indications May 19, 2026 -- Matter Bio today announced the submission of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for Lm-LLO-TT, the company's lead therapeutic candidate, for a first-in-human Phase 1/2a clinical trial in patients with pancreatic ductal adenocarcinoma (PDAC). If the IN

In a head-to-head psoriatic arthritis trial, UCB's Bimzelx achieved reduced disease activity in 49% of patients vs. 38% of those on AbbVie's Skyrizi. Bimzelx showed numerical superiority in secondary measures, but none that achieved statistical significance. Two months after UCB revealed the success of Bimzelx in a head-to-head trial against AbbVie’s Skyrizi in patients with psoriatic arthritis (PsA), the Belgian drugmaker has unveiled the detailed results. In the phase 3b study that included

The Xofluza license deal between Roche and the Medicines Patent Pool comes as ongoing hantavirus and Ebola outbreaks have once again thrust pandemic preparedness into the spotlight. (Roche/Genentech) Roche has signed a voluntary license agreement providing its popular influenza antiviral drug Xofluza (baloxavir marboxil) for generic drugmakers to copy in 129 developing countries. The deal with the Medicines Patent Pool will enable generic supply of baloxavir in 129 low- and middle-income count

Exelixis has secured supplies of subcutaneous Keytruda from Merck & Co. for a planned phase 3 study, completing the trio of contributors needed to run the colorectal cancer trial. California-based Exelixis partnered with Natera on the trial in January. Natera is providing its molecular residual disease (MRD) test for use in the study, as it did for a Roche trial that supported a recent label expansion for Tecentriq. Echoing Roche’s strategy in a different indication, Exelixis will enroll patien

This endocrine essential advances the diagnosis, confirmation and monitoring of Canine Cushing's and Addison's May 19, 2026 -- Dechra is proud to announce the U.S. Food and Drug Administration's (FDA) approval of CosACTHen® (cosyntropin injection), the first and only cosyntropin specifically indicated for use in canine patients. This milestone reinforces Dechra's ongoing commitment to advancing veterinary endocrinology and providing veterinarians with innovative, high-quality solutions for endo

New preclinical data further demonstrate GLIX1's robust efficacy in a dose-dependent manner, with strong anti-tumor activity observed even at the lowest doses tested Results highlight GLIX1's potential to address the high unmet need for patients with GBM May 19, 2026 -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, and Hemispherian AS, a clinical-stage oncology company developing

First-patient dosing anticipated in the third quarter of 2026 in a U.S. Phase 1 study of a first-in-class dual PI3K/EGFR inhibitor May 19, 2026 -- MEKanistic Therapeutics, a biotechnology company developing first-in-class precision medicines designed to overcome cancer resistance mechanisms, today announced that the U.S. Food and Drug Administration has cleared the Investigational New Drug application for MTX-531, the company's lead oncology candidate. With the IND now in effect, MEKanistic may

$2.4 Million in H1 2026 Capital Raises Ahead of Phase 3b ENDURANCE Trial May 19, 2026 – BrainStorm Cell Therapeutics Inc. (OTCQB: BCLI), a leading developer of adult stem cell therapies for neurodegenerative diseases, today announced that in May it entered into definitive agreements for a private placement yielding gross proceeds of $400,000. The transactions were priced at $0.95 per share, representing a 37.6% premium over the previous day's closing price of $0.69. Investors will also receive

First participant with Parkinson’s disease dosed at the Centre for Human Drug Research in the Netherlands May 19, 2026 -- Vertero Therapeutics, a clinical-stage biotechnology company breaking barriers in neurodegenerative disease treatment, today announced that the first patient with Parkinson’s disease (PD) has been dosed in the Phase 1b portion of its study of its lead candidate VT-5006, a first-in-class, gut-selective small molecule in development to address the significant unmet needs of pe

Enrollment milestone follows FDA IND clearance received in March 2026 and Danish Medicines Agency (DKMA) approval received in April 2026 May 18, 2026 -- Enlivex Ltd. (Nasdaq: ENLV) ("Enlivex" or the "Company"), a quality longevity company powered by a prediction markets treasury, today announced the dosing of the first patient at a United States clinical site in the Phase 2b clinical trial of Allocetra™ for the treatment of patients with moderate-to-severe age-related symptomatic primary kne