Endo International plc of Dublin, Ireland recently launched shipping operations for its generic Sabril (vigabatrin for oral solution USP, 500 mg) product via Par Pharmaceutical, following final approval of its Abbreviated New Drug Application (ANDA). Read More »
Orfadin, a drug used to treat a condition causing kidney and liver damage, has now received the FDA’s go-ahead for once-a-day use, cutting its dosing frequency in half. Read More »
Accorda Therapeutics Inc. recently announced that the U.S. Food and Drug Administration (FDA) provided a Refusal to File (RTF) letter regarding the company’s New Drug Application (NDA) for Inbrija, an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Read More »
Novo Nordisk recently announced that the U.S. Food and Drug Administration approved a new indication for Victoza, which should help reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease. Read More »
With the goal of treating dyskinesia in certain Parkinson’s disease patients, Adamas Pharmaceuticals of Emeryville, California recently obtained U.S. Food and Drug Administration approval for its Gocovri (amantadine) extended release capsules. Read More »
BioMarin Pharmaceuticals' Biologics License Application (BLA) for pegvaliase, a PEGylated recombinant phenylalanine ammonia lyase enzyme product, has been accepted for Priority Review by the U.S. Food and Drug Administration. Read More »
Genentech, a member of the Roche Group, recently announced that its drug Actemra received approval from the U.S. Food and Drug Administration (FDA). Read More »
Murray Hill, New Jersey-based surgical product producer and marketer C. R. Bard recently obtained premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its Lutonix 035 drug coated balloon PTA catheter (DCB). Read More »
Soliciting marketing approval for a medication addressing major depressive disorder, Alkermes PLC recently began a rolling submission of a New Drug Application regarding its ALKS 5461 product, expecting completion by the end of 2017. Read More »
AstraZeneca and Merck & Co. Inc. recently announced that their collaborative PARP inhibitor, Lynparza, received approval from the U.S. Food and Drug Administration (FDA). 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 »
An innovative treatment for certain types of acute lymphoblastic leukemia (ALL).1 — Pfizer’s Besponsa (inotuzumab ozogamicin) — recently obtained approval from the U.S. Food and Drug Administration via its Breakthrough Therapy designation and Priority Review programs. Read More »
Jerusalem-based Teva Pharmaceutical Industries Ltd. recently began marketing generic Axiron (testosterone) topical solution CIII, 30 mg/1.5 mL, in the United States for treating adult males who are experiencing low testosterone levels due to medical reasons. Read More »
A resubmitted Biologics License Application from California-based Portola Pharmaceuticals was recently deemed acceptable for review by the U.S. Food and Drug Administration and assigned an expected action due date of Feb. 2, 2018. Read More »
Sweden’s research-oriented pharmaceutical firm Medivir AB's Investigational New Drug application for an osteoarthritis treatment has been accepted by, and is currently open with, the U.S. Food and Drug Administration. Read More »
Arcadia Biosciences Inc. and Bioceres S.A. have entered a joint venture titled Verdeca, and announced that the company’s safety evaluation for HB4 soybeans received a full review by the U.S. Food and Drug Administration. Read More »
Apollo Endosurgery Inc. recently announced an update and clarifications to a letter sent by the U.S. Food and Drug Administration to health care providers about potential risks with liquid-filled intragastric balloons. Read More »
Arcadia Biosciences Inc., an agricultural technology company, recently received FDA approval from the U.S. Food and Drug Administration for the use of its safflower oil in dog diets. Read More »
Regeneron Pharmaceuticals Inc. recently announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus (RSV), failed to meet its primary endpoint. Read More »
Achieving U.S. Food and Drug Administration priority review status for its New Drug Application, Gilead Sciences Inc. recently made strides towards realizing an investigational, fixed-dose product combining several drugs to address HIV-1 infection. Read More »
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