Enrollment completed for the 6-week interim analysis with 24 of the 36 planned patients now enrolled Company on track to report interim biomarker data from the first 12 patients imminently Completion of patient enrollment and topline results expected Q3 2025 May 07, 2025 -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune dise

Topline data shows statistically significant improvement in overall survival in elraglusib plus GnP combination arm versus GnP control arm Elraglusib/GnP combination arm demonstrated substantial improvement in median overall survival since the last data analysis Clinical trial meets primary endpoint for overall survival and confirms significant 1-year survival rate Elraglusib/GnP combination arm demonstrated a favorable risk-benefit profile Topline dataset to be presented in an oral presentation

Meaningful Fatigue score reduction seen in study is a critically important quality of life (QoL) measure for Multiple Sclerosis patients. All patients experienced stabilization of Expanded Disability Status Scale (EDSS) scores. TSPO-PET imaging showed significant reductions in microglial activation at six months (p<0.05). May 06, 2025 -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with it

May 6, 2025 – Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to givinostat for the treatment of patients with polycythemia vera (PV), a rare haematologic cancer, for which treatment options are limited. “The FDA decision to grant givinostat Fast Track designation underscores the urgent need for innovative treatments for PV and highlights the potential of givinostat to make a meaningful difference,” said Paolo Bettica, MD, P

Radiopharmaceuticals, which combine radioactive isotopes with specific molecular carriers, are ushering in a new era of personalized medicine. These specialized drugs precisely target diseased tissues within the human body and release ionizing radiation for diagnostic or therapeutic purposes, significantly enhancing the accuracy and effectiveness of disease management. From traditional thyroid function tests to their current widespread application in cancer, cardiovascular diseases, and neurodeg

GAL-101 well tolerated; excellent safety and pharmacokinetic profile strongly supports oral administration Next arms of study, including multiple ascending dose (MAD), underway and expected to complete in late 2025 Planned indications include dry age-related macular degeneration (AMD), glaucoma and Alzheimer’s disease May 06, 2025 -- Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the po

-- Data will be featured at EULAR Annual Congress – May 06, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced new data from its ongoing Phase 1 study of its gene therapy candidate PCRX-201 (enekinragene inzadenovec). The data is being presented at the 2025 European Alliance of Associations for Rheumatology (EULAR) Annual Congress, taking pl

- FDA RMAT designation recognizes encouraging early data from Opus’ Phase 1/2 trial in patients with LCA5, an ultra-rare inherited retinal disease May 06, 2025 -- Opus Genetics, Inc. (Nasdaq: IRD), a clinical-stage ophthalmic biotechnology company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and other ophthalmic disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to

Last patient first visit (LPFV) marks completion of enrollment of 127 adult and elderly patients in the randomized, placebo-controlled trial -- topline data is expected in Q4 2025 This study builds on Phase 2a proof-of-concept results, which showed a clinically meaningful placebo-corrected reduction in pain and favorable tolerability of NRD.E1 in patients with painful diabetic peripheral neuropathy (PDPN) [1] 6 May 2025 – Novaremed AG, a privately held clinical-stage biopharmaceutical company,

May 2, 2025 – Bavarian Nordic A/S (OMX: BAVA) announced today that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for VIMKUNYA® (recombinant, adsorbed) for active immunization for the prevention of disease caused by chikungunya virus in individuals 12 years and older. The vaccine was approved following MHRA review under the international recognition procedure, which is a targeted assessment that recognizes approva