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

- 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

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

July 22, 2026 -- Monopar Therapeutics Inc. (“Monopar” or the “Company”) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company developing innovative treatments for patients with unmet medical needs, today announced that it has initiated the rolling submission of a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for ALXN1840 (tiomolibdate choline, TMC), its first-in-class albumin tripartite complex (“ATC”) activator for the treatment of Wilson disease. The FDA ha

- PDUFA target action date of May 8, 2027 - If approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1, representing a potential blockbuster opportunity for BridgeBio- Encaleret demonstrated consistent efficacy across all pre-specified primary and key secondary efficacy endpoints normalizing key markers of CaSR-driven disease biologywithout the need for calcium and vitamin D supplements, with a favorable safety and tolerability prof

July 20, 2026 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") today announced that the first patient has been dosed in a Phase II clinical study (AK146D1-201) evaluating its internally developed TROP2/Nectin-4 bispecific antibody-drug conjugate (ADC), AK146D1, in combination with ivonescimab (the Company's PD-1/VEGF bispecific antibody) in patients with advanced non-small cell lung cancer (NSCLC). The study will explore the therapeutic potential of this combination, with a particular emphasi