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 »
Neovacs, a company focusing on immunotherapies that treat autoimmune diseases, recently announced its Investigation New Drug application for IFNalpha Kinoid was cleared by the U.S. Food and Drug Administration. 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 »
To better assess patients’ oral and pharyngeal functioning for the purpose of easing swallowing disorders, the U.S. Food and Drug Administration recently approved Bracco Diagnostics Inc.’s Varibar Nectar (barium sulfate) Oral Suspension. 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 »
Filling a need for those youngsters who fear needles or find pills unmanageable, Denver-based Silvergate Pharmaceuticals Inc. recently released Xatmep, the first methotrexate oral solution to gain approval from the U.S. Food and Drug Administration. Read More »
In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration (FDA) recently issued a Complete Response Letter. Read More »
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