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 »
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 »
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 »
Vical Inc. and Astellas Pharma's Phase 2 study of cytomegalovirus vaccine ASP0113 has achieved topline results. Read More »
Corvus Pharmaceuticals presented preclinical data from its Phase1/1b study of CPI-444, and preliminary biomarker data from the trial. Read More »
Elusys Therapeutics has published data from five clinical trials of ANTHIM, which was used to support the marketing approval by the U.S. Food and Drug Administration. Read More »
Apintyx Inc. will develop its lead compound, NYX-2925, to treat neuropathic pain linked to diabetic peripheral neuropathy. Read More »
Avara Pharmaceutical Services Inc. recently celebrated the one-year anniversary of its purchase of the Arecibo site in Puerto Rico from Merck. Read More »
CVS Health reported this week that it has increased access to naloxone, the opioid overdose-reversal medication, to include five new states — Alabama, Alaska, Illinois, Missouri and West Virginia. Read More »
AbbVie recently announced that the small molecule active pharmaceutical ingredient (API) facility constructed at its Singapore manufacturing site is now open. Read More »
Allergan Inc. recently announced the acquisition of Akarna Therapeutics for an upfront payment of $50 million. Read More »
Abbott announced this week that its FreeStyle Libre Pro system, a groundbreaking continuous glucose monitoring (CGM) system designed for patients with diabetes, has been approved by the U.S. Food and Drug Administration (FDA).re Read More »
Perrigo Co. this week announced that it has agreed to an exclusive licensing agreement with Highland Pharmaceuticals LLC for its methamphetamine (meth) blocking technology called Tarex. Read More »
Jazz Pharmaceuticals plc recently reported that enrollment for its two Phase 3 clinical trials for JZP-110 has been finalized. Read More »
Amgen recently reported top-line results of its Phase 3 CLARION trial that was designed to assess KYPROLIS (carfilzomib), melphalan and prednisone (KMP), Amgen's new investigational regimen, while comparing it to Velcade (bortezomib). Read More »
Tarix Orphan LLC recently announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Status to TXA127, the company’s prospective treatment for Recessive Dystrophic Epidermolysis Bullosa (RDEB), a rare genetic skin disorder. Read More »
Armetheon Inc., a specialty pharmaceutical company that focuses on the development of novel small molecule drugs for the treatment of cardiovascular diseases, recently released the results of its Phase 1 clinical trial assessing how the pharmacokinetics (PK) of tecarfarin and of warfarin is affected by severe chronic kidney disease (CKD). Read More »
Allergen plc recently announced that NAMZARIC is now available through prescription in pharmacies across the United States. Read More »
Mylan N.V. and Biocon Ltd. recently announced that Mylan’s Marketing Authorization Application (MAA) for Trastuzumab has been accepted by the European Medicines Agency (EMA) for review. Read More »
PharmaMar recently submitted a Marketing Authorization Application (MAA) for Aplidin to the European Medicines Agency (EMA). Read More »
Mark Merritt, president and CEO of the Pharmaceutical Care Management Association (PCMA), recently testified before the House Judiciary Subcommittee on Regulatory Reform, Commercial and Antitrust Law. Read More »