– A Second Approval in First-Line Would Establish Trodelvy as a Backbone Therapy Across PD-L1 Status in the European Union – – ASCENT-04/KEYNOTE-D19 Demonstrated a Highly Statistically Significant and Clinically Meaningful Reduction in the Risk of Disease Progression or Death – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing author

Eli Lilly plans to file for FDA approval of retatrutide in the first quarter of 2027 after the so-called 'triple-G' drug, which targets the GIP, GLP-1 and glucagon receptors, delivered "substantial" weight loss in two further late-stage obesity studies. The company said Thursday that it is currently completing the Chemistry, Manufacturing, and Controls (CMC) data package required for the submission. "With the positive results from TRIUMPH-2 and TRIUMPH-3, we now have the clinical data package t

US$4.6 million financing fully capitalizes N-Zyme Biomedical’s planned Phase 2 clinical programs in laryngopharyngeal reflux and PPI-refractory GERD, supporting the advancement of its first-in-class pepsin-targeted therapeutic approach. N-Zyme Biomedical today announced the successful closing of its Series A financing, raising approximately US$4.6 million to accelerate the advancement of its Phase 2 clinical programs and further the development of its novel pepsin inhibitor platform for refl

- This marketing authorization is the first for IZCARGO™ outside of Japan - JCR Pharmaceuticals Co., Ltd. (TSE 4552; “JCR”), a global specialty biopharmaceutical company dedicated to developing therapies for rare and genetic diseases, today announced that IZCARGO™ (pabinafusp alfa, or JR-141), a blood-brain barrier-penetrating enzyme replacement therapy (ERT) for Hunter syndrome developed using JCR’s proprietary J-Brain Cargo® technology, received marketing authorization in the United Arab Emir

Lee’s is eligible to receive up to $31 million in upfront and milestone payments. Ashlins Pharmaceuticals today announced that its wholly owned subsidiary, Ashlins Ocular Pharmaceuticals, Inc., has entered into an exclusive license and supply agreement with Lee’s Pharmaceutical Holdings Limited (HKEX: 0950), a publicly listed biopharmaceutical company with more than 30 years of industry experience. Under the agreement, Ashlins has obtained exclusive rights to develop and commercialize certain

July 23, 2026 -- AnHorn Medicines today announced the successful completion of the first subject first dose in the Phase I clinical trial of AH-008, a first-in-class neuroprotective candidate being developed to prevent chemotherapy-induced peripheral neuropathy (CIPN). This milestone marks the clinical advancement of a novel therapeutic approach designed to address one of the most common and debilitating complications of cancer treatment. Chemotherapy-induced peripheral neuropathy (CIPN) is a fr

Company formed to advance SYN-001, an FDA-designated orphan and rare pediatric disease therapeutic candidate acquired from Nobias Therapeutics Phase IIb trial planned to further evaluate SYN-001 for the treatment of neuropsychiatric symptoms associated with 22q11.2 Deletion Syndrome (22q11DS) JULY 23, 2026 -- A consortium of European and US-based investors and Nobias Therapeutics today announced the launch of Synaptiq Therapeutics, a privately held, clinical-stage biotechnology company dedicate

July 23, 2026 -- Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, today announced that dosing has begun in a Phase 1 clinical study evaluating BAT8013, an antibody drug conjugate (ADC) that targets CD25. The clinical trial is a multicenter, open-label Phase 1 clinical study in patients with advanced solid tumors to evaluate the safety and tolerability of BAT8013 and to determine the recommended Phase 2 dose. CD25, also known as interleukin-2 receptor alpha chai

The U.S. FDA has granted Fast Track designation to Lu AH69593, an oral orexin 2 receptor agonist, for the treatment of patients with narcolepsy The orexin 2 receptor is critically located in the main biological pathway involved in wakefulness and sleep-wake regulation Lu AH69593 is currently in Phase 1b development for patients with narcolepsy The designation marks an important regulatory milestone as Lundbeck advances a portfolio of programs for people living with sleep-wake disorders July 23,

July 23, 2026 -- Haisco Pharmaceutical Group claimed today their independently developed Class 1 innovative drug, Ciprocopan Succinate Tablets (development code: HSK39297), has received marketing approval from the National Medical Products Administration of China (NMPA) for the treatment of adult patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who are complement-inhibitor-naïve. This is Haisco's fifth innovative drug approved for marketing and represents an important advance in the treat