Dec. 04, 2024 -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced that it has engaged New Growth Advisors (“NGA”), a leading life sciences consulting firm chosen by companies seeking discreet, conflict-free, and knowledgeable advice on complex M&A, asset sale, research, capital markets, and licensing transactions, as its strategi

First positive reimbursement decision worldwide for LYTENAVA™; First launch anticipated in H1 2025 LYTENAVA™ is the first and only approved ophthalmic formulation of bevacizumab for the treatment of wet AMD in the European Union (EU) and United Kingdom (UK) 40,000 new wet AMD patients each year in the UK who could benefit from treatment1 Dec. 04, 2024 -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United

Antibody levels remained high at 96% seroresponse in line with the two-year persistence data This long-lasting antibody persistence was comparable in older (65+) and younger adults December 3, 2024 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today reported positive antibody persistence data three years after vaccination with a single dose of its chikungunya vaccine IXCHIQ®. The results are in line with Valneva’s expectations for this vaccine, confirming a stron

Inherited SP-B deficiency is an ultra-rare monogenic cause of fatal respiratory distress syndrome in newborn infants with few, if any, options for long-term survival Highly encouraging preclinical data highlight the possibility of lifelong treatment from a single administration of AVG-002 with preparations for clinical development underway Follows recent grant of Rare Pediatric Disease Designation from FDA 3 December 2024 – AlveoGene (or ‘the Company’, www.alveogene.com), a company focused on tr

— First regulatory approval for fruquintinib combination therapy with an immune checkpoint inhibitor — Dec. 03, 2024 -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) and Innovent Biologics, Inc. (“Innovent”) (HKEX:1801) today jointly announce that the New Drug Application (“NDA”) for the combination of ELUNATE® (fruquintinib) and TYVYT® (sintilimab injection) has been granted conditional approval in China for the treatment of patients with advanced endometrial cancer with Mi

Namilumab failed to show treatment benefit in patients with pulmonary sarcoidosis Further development of namilumab for the treatment of sarcoidosis will be discontinued Dec. 03, 2024 -- Kinevant Sciences, a clinical-stage biopharmaceutical company developing new medicines for rare inflammatory and autoimmune diseases, today announced its Phase 2 study failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. The Phase 2 RESOLVE-Lung study (NCT05314517) evaluated th

Dec. 02, 2024 -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act (PDUFA) target action date of September 26, 2025. The FDA is not currently planning to hold an advisory committee me

Dec. 02, 2024 -- AAVantgarde Bio (AAVantgarde), a clinical-stage, Italian-based international biotechnology company with two proprietary Adeno-Associated Viral (AAV) vector platforms for large gene delivery, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead program, AAVB-081 for the treatment of Usher Syndrome Type 1B (USH1B) retinitis pigmentosa. “People living with USH1B are in urgent need of a therapy to prevent their progressiv

Reaffirms New Drug Application (NDA) first quarter 2025 submission guidance Confirms no additional adult clinical trials are necessary prior to NDA submission Commenced pediatric trial in the U.S. and Canada Dec. 02, 2024 -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies (“Aquestive,” the “Company” or “we”), today announced receipt of positive feedba

Fast Track designation is designed to expedite clinical development and regulatory review timelines Enrolling patients in the GLEAM trial for SC291 in B-cell mediated autoimmune diseases, including systemic lupus erythematosus; expect to report initial clinical data in 2025 Dec. 02, 2024 -- Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on changing the possible for patients through engineered cells, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track