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 »
Imprimis Pharmaceuticals Inc. recently released a statement after the MedWatch notification put forth by the U.S. Food and Drug Administration. Read More »
AbbVie's once-daily treatment for chronic hepatitis C virus (HCV) infection, Mavyret, has been approved by the U.S. Food and Drug Administration. Read More »
La Jolla Pharmaceutical Co. recently initiated an expanded access program (EAP) in the United States for its investigational drug LJPC-501. Read More »
AstraZeneca and Acerta Pharma's treatment for patients with mantle cell lymphoma who have received at least one prior therapy was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration. Read More »
Pfizer Inc.'s proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis received recommendation for approval by the U.S. Food and Drug Administration’s Arthritis Advisory Committee via a 10-1 vote. Read More »
International pharmaceutical provider Mylan recently obtained what it called tentative approval of its New Drug Application for an antiretroviral formula to circulate as a preferred treatment for HIV/AIDS patients in developing nations. Read More »
Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia. Read More »
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