Duzallo gains FDA approval to treat patients with gout
The U.S. Food and Drug Administration has approved Ironwood Pharmaceuticals Inc.'s drug Duzallo, a once-daily oral treatment to fight hyperuricemia associated with gout in patients. Read More »
The U.S. Food and Drug Administration has approved Ironwood Pharmaceuticals Inc.'s drug Duzallo, a once-daily oral treatment to fight hyperuricemia associated with gout in patients. Read More »
Thermo Fisher Scientific recently received U.S. Food and Drug Administation 510(k) clearance for the company’s new immunoassay for the specific detection of buprenorphine and its three major metabolites. Read More »
Celgene Corp. and Agios Pharmaceuticals Inc. recently received U.S. Food and Drug Administration approval for IDHIFA as a treatment for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. Read More »
Following successful clinical results, Vertex Pharmaceuticals Inc. recently gained approval from the U.S. Food and Drug Administration (FDA) to treat more than 600 cystic fibrosis (CF) patients with its proprietary Kalydeco (ivacaftor) product. Read More »
Boston-based biopharmaceutical firm Parexel International Corp. has had two of its leaders earn a place on PharmaVOICE magazine’s annual list of the life science industry’s top 100 “inspiring people” for their overall industry contribution and highest level of commitment. Read More »
Formulated to detect the presence of the potent opioid fentany in urine, California-based Immunalysis Corp.’s branded immunoassay Sefria — the first of its kind — recently achieved 510(k) clearance from the U.S. Food and Drug Administration. Read More »
Thermo Fisher Scientific Inc. recently announced the availability of a fully integrated solution for polymer-based drug implant development and production using hot melt extrusion (HME). Read More »
Sunovion Pharmaceuticals Inc. of Marlborough, Massachusetts recently gained approval for its supplemental new drug submission regarding Latuda (lurasidone HCI) — aimed at relieving adolescent schizophrenia — from Health Canada, potentially extending the treatment’s age range. Read More »
EMD Serono, the biopharmaceutical business of Merck KGaA in the United States and Canada, recently showcased 14 presentations at the 31st Annual Meeting of the Consortium of Multiple Sclerosis Centers, including eight sets of data on Cladribine Tablet, a treatment for patients with relapsing multiple sclerosis. Read More »
Test detects five most commonly misused and abused prescription drugs; five-minute results will facilitate rapid interventions in prescription drug abuse. Read More »
Merck KGaA will collaborate with F-Star, a biopharmaceutical company in the United Kingdom, to develop and commercialize five bispecific immuno-oncology antibodies. Read More »
Two third generation hepatitis B vaccine trials to enroll 4,800 participants in the U.S., Canada and Europe. Read More »
Sunovion Pharmaceuticals Inc.'s supplemental New Drug Application for a medication addressing bipolar conditions has won acceptance for review by the U.S. Food and Drug Administration. Read More »
The U.S. Patent Office published Citius Pharmaceuticals' patent application for enhanced stability of antimicrobial solutions for locking central venous catheters. Read More »
Enanta Pharmaceuticals Inc.'s New Drug Application (NDA) for its pan-genotypic regimen of glecaprevir/pibrentasvir (G/P), developed in conjunction with AbbVie, has been accepted by the U.S Food and Drug Administration. Read More »
Spinraza (nusinersen) recently won European Commission authorization to treat 5q SMA — the most common form of spinal muscular atrophy — becoming the first such drug to achieve European approval, manufacturer Biogen announced from Cambridge, Massachusetts. Read More »
The FDA says it is willing to look into and evaluate a drug that could help treat children who suffer from seizures. Read More »
Abbott recently announced that its molecular test, the Abbott RealTime Zika Test, has been authorized by the U.S. Food and Drug Administration (FDA). Read More »
Concert Pharmaceuticals Inc. has received a second request from the Federal Trade Commission for the acquisition of CTP-656, as well as other options for cystic fibrosis treatment, produced by Vertex Pharmaceuticals Inc. Read More »
Valeant Pharmaceuticals Inc. and EyeGate Pharmaceuticals have entered an exclusive, global licensing agreement. Read More »