Vical, Astellas announce ASP0113 trial achieves topline results
Vical Inc. and Astellas Pharma's Phase 2 study of cytomegalovirus vaccine ASP0113 has achieved topline results. Read More »
Diffusion completes animal toxicology studies
Diffusion Pharmaceuticals has completed the dosing of two animal toxicology studies that are required by the U.S. Food and Drug Administration for approval of Diffusion’s lead molecule trans sodium crocetinate Phase 3 trial. Read More »
Bayer announces FDA approval of Kyleena
The U.S. Food and Drug Administration has approved Bayer's progestin-containing intrauternine system Kyleena for pregnancy prevention for a span of up to five years. Read More »
Epizyme to partner with Foundation Medicine for tazemetostat trial
Epizyme Inc. has agreed to a partnership with Foundation Medicine to identify and enroll support patients for the upcoming Phase 2 trial of tazemetostat on patients who have non-Hodgkin lymphoma. Read More »
Pacira launches non-opioid EXPAREL for relief from dental pain
Pacira Pharmaceuticals has released new data supporting EXPAREL and the benefits it could offer patients who must undergo third molar, or wisdom teeth, removal. Read More »
Mucodel Pharma concludes successful Exonal clinical trial
Mucodel Pharma, a private company based in Greensboro, North Carolina, that is dedicated to the development of improved rescue therapies to be administered oromucosally, has completed its Exonal (buccal naloxone) clinical study. Read More »
Amgen’s AMJEVITA approved to treat inflammatory diseases
The U.S. Food and Drug Administration has approved Amgen’s AMJEVITA for the treatment of seven different inflammatory diseases. Read More »
Ajanta releases Omeprazole and Sodium Bicarbonate Powder for Oral Suspension in U.S.
Ajanta Pharma USA has made Omeprazole and Sodium Bicarbonate Powder for Oral Suspension available in the United States. Read More »
FDA approves update to Rexulti label
H. Lundbeck and Otsuka Pharmaceutical Development & Commercialization have reported that the U.S. Food and Drug Administration has approved the update to the Rexulti label. Read More »
Corvus releases CPI-444 Pahse 1/1b clinical study data
Corvus Pharmaceuticals has released the preclinical data and preclinical biomarker data from its Phase 1/1b CPI-444 clinical study. Read More »
AcelRx initiates IAP312 Phase 3 trial for study of Zalviso
AcelRx Pharmaceuticals has commenced with its IAP312 Phase 3 trial for the study of Zalviso, its new investigational product in development to treat moderate-to-severe acute pain in adult hospital patients. Read More »
FDA approves Athersys' Multistem Phase 3 trial
The U.S. Food and Drug Administration, under a Special Protocol Assessment, has agreed to Athersys' design and analysis of a Multistem Phase 3 study. Read More »
FDA gives fast-track approval for Medtronic’s MiniMed 670G
The U.S. Food and Drug Administration has given its approval of the MiniMed 670G hybrid closed looped system, designed to automatically monitor glucose and give suitable dose to individuals 14 years of age and older. Read More »
Eleventa finalizes Timapiprant trial enrollment
Eleventa, a portfolio company owned by Maxwell Biotech Venture Fund in association with its development partner Oxagen Ltd., has finalized patient enrollment for its Phase 3 Timapiprant clinical trial. Read More »
Bayer and DelSiTech announce Collaboration and Technology License Agreement
Bayer and DelSiTech have issued a joint announcement regarding the signing of a Collaboration and Technology License Agreement. Read More »
Amgen's ARISE trial produces positive results
Amgen's Phase 3 erenumab clinical trial has turned in positive results. Read More »
Teva launches generic version of Epzicom tablets in U.S.
Teva Pharmaceutical Industries has launched Abacavir and Iamivudine tablets, the company’s generic version of Epzicom tablets, in the United States. Read More »
FDA grants AbVie’s G/P regimen Breakthrough Therapy Designation
AbbVie's investigational, pan-genotype regimen of gelcaprevir (ABT-493) and pibrentasvir (ABT-530) has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration. Read More »
Regeneron receives positive trial results for CAPELLA
Regeneron Pharmaceutical's Phase 2 CAPELLA trial has turned in positive results. Read More »
First patients enrolled in Phase 3 CAM2038 trial
Braeburn Pharmaceuticals and Camurus have enrolled the first Phase 3 CAM2038 trial patients to assess the safety and effectiveness of CAM2038 in patients with lower back pain whose present course of treatment involves opioids. Read More »
Alerts Sign-up