Recommendation based on NEXUS data; Minoryx and Neuraxpharm expect European Commission approval by the end of this quarter July 24, 2026 -- Minoryx Therapeutics and Neuraxpharm Group, announce that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorisation approval under exceptional circumstances for NEZGLYAL® (leriglitazone) as a treatment for male cALD patients, aged 2-12 years with Gadolinium (Gd) negative brai

Company plans to request re-examination following negative CHMP opinion for arimoclomol MAA Zevra continues to support access to arimoclomol for eligible patients through its global Expanded Access Program July 24, 2026 -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on bringing life-changing therapeutics to people living with rare diseases, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Med

Enveda, a clinical-stage biotech company developing first-in-class small molecules derived from life’s chemistry, had results from its Phase 1b atopic dermatitis trial presented in New York at last week’s 2026 American Academy of Dermatology (AAD) Innovation Academy, and announced its acceptance for an oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2026 in Vienna. “Patients want oral therapies; the problem is with our current orals, we take safety penal

Susvimo is the first and only continuous delivery treatment that offers an alternative to standard of care eye injections for nAMD Positive recommendation is based on data from the LADDER, Archway and Portal studies showing Susvimo maintained vision equivalent to monthly intravitreal ranibizumab injections1-3 By continuously delivering medicine into the eye through the Contivue® refillable implant, Susvimo may help people with nAMD maintain their vision with as few as two treatments per year1-3

– 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

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,