MHRA granted on 6th May the Promising Innovative Medicine (PIM) Designation MHRA granted on 15th May the Marketing Authorisation, confirming the Orphan Drug Designation and the New Active Substance status CATANIA, Italy, May 19, 2025 /PRNewswire/ -- SIFI, a leading international ophthalmic company, today announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has granted the Marketing Authorization for AKANTIOR® (polihexanide 0.08%) confirming the Orphan Drug Desig

STOUGHTON, Mass., May 19, 2025 /PRNewswire/ -- Massachusetts based Trax Surgical, LLC, an orthopedic product development and distribution company principally serving the needs of the orthopedic extremities market, announced today that they received FDA 510(k) clearance to market the LINKT™ Compression Staple System. The staple system offers a range of nitinol staples for fracture repair, joint fusion, and osteotomy procedures. Continue Reading The LINKT™ System is comprised of a nitinol implant

PLANO, Texas, May 19, 2025 /PRNewswire/ -- AnX Robotica, a leader in robotic capsule endoscopy and advanced GI diagnostics, proudly announced the successful launch of NaviCam XS, NaviCam XST, and ESView 3.0 during Digestive Disease Week (DDW) 2025. The unveiling drew exceptional interest, with clinicians, researchers, and industry professionals visiting the AnX Robotica booth to witness the next evolution in GI visualization technology. Continue Reading NaviCam XS, the latest addition to the Nav

Korean ARPA-H to build AI-driven surgery assistant robot The Ministry of Health and Welfare (MOHW) in South Korea and the Korea Health Industry Development Institute (KHIDI) announced three additional projects under the Korean Advanced Research Projects Agency for Health (ARPA-H). One of these is an AI-powered assistant robot, which will be designed to perform repetitive tasks supporting doctors during surgeries. Its development aims to address the shortage of surgery staff. The other two new

Des Green/ iStock While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way. The current U.S. presidential administration under Donald Trump has begun to eliminate many federal regulatory staff while announcing plans to dramatically cut regulations. While administration officials, including senior advisor Elon Musk and U.S. Chamber President Suzanne P. Clark have touted potential fina

SAN FRANCISCO and SUZHOU, China, May 18, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the release of its "2024 Environmental, Social and Governance (ESG) Report", highlighting the Company's strategies, actions, and achievements in sustai

iStock/ francescoch While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability. While the FDA under HHS Secretary Robert F. Kennedy Jr. might seem to be worlds different than the FDA of 2024, the agency still seems to be prioritizing expediting treatments for rare diseases, particularly ultrarare conditions. As head of the F

After a weeks-long delay, Novavax's protein-based COVID-19 vaccine has at last been given full FDA approval, but in a more limited patient population than its mRNA counterparts.The jab, now called Nuvaxovid, was cleared for adults 65 years and older, or those between the ages of 12 and 64 who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.The two currently approved vaccines — Moderna's Spikevax, and Pfizer and BioNTech's Comirnaty — can be gi

Deep, durable and consistent reductions in TTR were sustained at two years, following a one-time dose of nex-z Clinically meaningful improvements in ATTRv-PN related outcomes observed at 24 months compared to baseline, including in patients who were previously progressing on patisiran Continue to observe generally favorable safety and tolerability data in the full Phase 1 cohort with no new drug-related adverse events within the follow-up period Enrollment continues to progress well in MAGNITUDE

Two New Analyses from SEQUOIA-HCM on Effect of Aficamten Between Patients with Mild and Moderate-to-Severe Symptoms, and Across Geographic Regions HEOR Analyses of Real-World Data Reveal Disparities in Outcomes In Females and Older Patients with Non-Obstructive HCM SOUTH SAN FRANCISCO, Calif., May 18, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that additional data arising from two analyses from SEQUOIA-HCM, (Safety, Efficacy, and Quantitative Understanding