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 »
Mitsubishi Tanabe Pharma America Inc. of New Jersey has reported that Radicava (edaravone), an intravenous therapy for adults with amyotrophic lateral sclerosis (ALS), is now available in the U.S. Read More »
The U.S. Food and Drug Administration recently accepted Genentech’s supplemental New Drug Application for Zelboraf (vemurafenib) — including breakthrough therapy designation — to address a form of Erdheim-Chester disease, a rare blood disorder. Read More »
The first eight-week medication cycle for chronic hepatitis C virus (HCV) recently earned approval from the U.S. Food and Drug Administration (FDA) in the form of Mavyret (glecaprevir and pibrentasvir), shortening treatment duration by one-third. Read More »
Resolving a contractual dispute dating to 2010 regarding three-way collaboration on Opana ER tablets — between Impax Laboratories, Endo International plc and Penwest Pharmaceuticals — Impax recently revealed a mutual settlement agreement from its Hayward, California hub. Read More »
An innovative new asthma treatment from Teva Pharmaceutical Industries Ltd. recently gained U.S. Food and Drug Administration approval, permitting the breath-activated inhaler to enter the market as a prophylactic maintenance medication. Read More »
Making progress in the fight against opioid abuse, California-based Opiant Pharmaceuticals Inc. recently obtained a U.S. patent for its 2mg formula of Narcan Nasal Spray and product inclusion in U.S. Food and Drug Administration’s listings. Read More »
Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration. 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 »
Amgen and Allergan submitted a Biologics License Application for ABP 980, a biosimilar candidate to Herceptin, to the U.S. Food and Drug Administration. Read More »
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