X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)
X-Therma Inc., a biotechnology company developing a breakthrough platform for regenerative medicine and organ preservation, announces that the Food and Drug Administration (FDA) accepted a Drug Master File (DMF) covering its product, XT-Thrive®. This DMF covers the Chemistry, Manufacturing and…
vTv Therapeutics Announces FDA Submission for First Phase 3 Study of Cadisegliatin in Patients with Type 1 Diabetes
vTv Therapeutics Inc. (Nasdaq: VTVT), a clinical stage biopharmaceutical company focused on the development of cadisegliatin (TTP399) as an adjunctive therapy to insulin for the treatment of type 1 diabetes (“T1D”), today announced the submission of the study protocol to the FDA…
SpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN
SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)…
Danone North America Announces the FDA’s Decision on Their Petition for the First-Ever Qualified Health Claim for Yogurt, Linking This Dairy Aisle Staple to a Reduced Risk of Type 2 Diabetes
In response to a petition submitted by food and beverage leader Danone North America, the U.S. Food and Drug Administration (FDA) today announced the first-ever qualified health claim for yogurt, recognizing a potential link between its regular consumption and a reduced…
Cullinan Oncology Announces U.S. FDA Clearance of Investigational New Drug Application for Novel MICA/B Antibody, CLN-619, for Relapsed/Refractory Multiple Myeloma
Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class…
PCM Trials Acquires EmVenio Research to Create the Most Patient-Centric Model for Hybrid and Decentralized Clinical Trials
Denver-based PCM Trials, the largest independent mobile research nurse visit provider for decentralized clinical trials (DCTs), today announced the acquisition of EmVenio Research based in Durham, North Carolina. EmVenio is the largest provider of community-based clinical trial sites served with mobile research units. The…
The New England Journal of Medicine Publishes Positive Phase 3 RESPONSE Data of CymaBay’s Seladelpar in Primary Biliary Cholangitis
CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a biopharmaceutical company focused on innovative therapies for patients with liver and other chronic diseases, today announced that The New England Journal of Medicine (NEJM) has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar, an…
PharmaTher’s Sairiyo Therapeutics Inc. Advances Clinical Development of Patented Reformulated Cepharanthine for Phase 1 Study in Australia
PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, announced today Sairiyo Therapeutics Inc. (“Sairiyo”), a company that is forty-nine percent (49%) owned by PharmaTher and fifty-one percent (51%) owned by PharmaDrug Inc. (CSE:…
United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease
Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from…
Brii Biosciences Announces Agreement to Acquire VBI’s IP Rights in BRII-179 (VBI-2601) and Plans to Initiate Technology Transfer to Expand Clinical and Commercial Supplies
Brii Biosciences Limited (“Brii Bio,” “we,” or the “Company”, stock code: 2137.HK), a biotechnology company developing therapies to improve patient health and choice across diseases with high unmet needs, today announced that it has entered into agreements with VBI Vaccines, Inc….
