Application based on long-term safety and efficacy data from three ongoing studies, including adult height and additional clinical outcomes beyond linear growth, including body proportionality and arm span evaluated over long-term follow-up FDA PDUFA target action date of Feb. 28, 2027 July 13, 2026 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for V

Boehringer Ingelheim’s Jascayd (nerandomilast) tablets have been granted marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with idiopathic pulmonary fibrosis (IPF) and adults with progressive pulmonary fibrosis (PPF). Jascayd is the first treatment of its kind licensed for use in IPF and PPF in adults. The MHRA authorisation is based on the results of the pivotal phase 3 clinical trials involving 1,177 and 1,176 patients with IPF and PPF r

July 10, 2026 -- SL Science Holding Limited (“SL Science” or the “Company”) (Nasdaq: SLBT), a Taiwan-headquartered biomedical company specializing in developing innovative cellular and gene therapies, today announced that the Company has submitted an Orphan Drug Designation (ODD) request to the U.S. Food and Drug Administration (FDA) for its Gamma Delta T (GDT) cell therapy product, Vdelta2+ Gamma Delta T Cells, for the treatment of glioblastoma multiforme (GBM). The FDA's Office of Orphan Produ

July 13, 2026 -- Delonix Bioworks, a clinical-stage biotechnology company pioneering genetically engineered bacterial vaccines, today announced that the first participant has been dosed in its Phase 1 clinical trial of DX-104 in China. DX-104 is an innovative Group B meningococcal (MenB) vaccine candidate developed using the company's proprietary OMV Plus® platform. This milestone marks a significant step in the concurrent global development of DX-104, following the initiation and ongoing progre

On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvant treatment after cystectomy (surgery to remove the bladder) for adults with muscle invasive bladder cancer (MIBC). This extends the prior approval for the regimen in this setting from patients who ar

Findings demonstrate significant improvements in major disruptive menopausal symptoms and a beneficial increase in E2/E1 ratio July 9, 2026 -- Elysium Health, Inc.™, the leading longevity science company, today announced new research published in Frontiers in Aging demonstrating significant improvements in disruptive menopausal symptoms in women taking Basis™, the company's flagship product clinically proven to raise NAD+ levels. The study also showed a significant increase in the ratio of estr

Ipsen announced Thursday that Dysport (abobotulinumtoxinA) hit the mark in a pair of late-stage trials, marking the first time a botulinum toxin has shown efficacy across both chronic and episodic forms of migraine. The Phase III BEOND programme enrolled 1510 adults across two studies — C-BEOND and E-BEOND — pitting Dysport against placebo, with the trials' primary efficacy endpoint being change in monthly migraine days at week 24. Top-line results showed Dysport met its primary goals in both

New patent application published covering chemically novel FAK inhibitors discovered by Amplia Application expands Amplia’s intellectual property portfolio supporting its FAK inhibitor program If granted, patent protection for the new molecules and their use would extend to 2046 New compounds broaden pipeline optionality and may support future development and partnering opportunities July 09, 2026 -- Amplia Therapeutics Limited (ASX:ATX; OTCQB:INNMF), (“Amplia” or the “Company”), is pleased to

ART5803 is a precision therapeutic candidate designed to directly inhibit the pathogenic effects of anti-NMDA receptor autoantibodies Fast Track designation enables a more expedited regulatory review of ART5803, which has also received U.S. FDA Orphan Drug and Rare Pediatric Disease designations, as well as Orphan Drug designation from South Korea’s MFDS. Arialys Therapeutics, a clinical-stage biotechnology company pioneering precision medicines for autoimmune neuropsychiatric diseases, today

July 8, 2026 -- Keenova Therapeutics plc announced today positive results from its Phase 3 clinical trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of plantar fibromatosis, a chronic medical condition that causes nodules composed primarily of excess collagen to form in the connective tissue that supports the arch of the foot. The pivotal trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in pain versus placeb