Moleculin Biotech comments on FDA approvals for AML drugs
Moleculin Biotech Inc. recently released comments regarding recent FDA approvals for new drugs that treat acute myeloid leukemia. Read More »
Radicava attains FDA approval for ALS treatment
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 »
FDA approves Genentech’s Zelboraf for rare blood disease
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 »
FDA approves Mavyret for hepatitis C virus
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 »
Impax Labs settles with parties on Opana ER rights
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 »
Teva’s unique asthma inhaler gains FDA approval
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 »
Opiant obtains ‘Orange Book’ approval for Narcan Nasal Spray
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 »
Epclusa now approved to treat HCV/HIV co-infections
Gilead Sciences Inc.'s updated labeling for Epclusa has been approved by the U.S. Food and Drug Administration. Read More »
Thermo Fisher Scientific's new opioid treatment gains 501(k) clearance
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 submit biosimilar candidate for Herceptin
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 »
Neovac moves forward with dermatomyositis treatment
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 »
Collaborative drug for AML gains FDA approval
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 »
Vertex nets FDA approval for Kalydeco to treat cystic fibrosis
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 »
Bracco obtains FDA approval for Varibar Nectar Oral Suspension
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 »
Immunalysis’ Sefria earns FDA approval for opioid screening
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 »
Silvergate delivers FDA-approved oral med Xatmep for children
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 »
Eagle Pharmaceuticals receives FDA reply for Ryanodex
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 »
Teligent's topical erythromycin gel receives FDA approval
New Jersey-based specialty generic pharmaceutical manufacturing firm Teligent recently obtained U.S. Food and Drug Administration approval — its third in 2017 — for its Abbreviated New Drug Application (ANDA) regarding its Erythromycin Topical Gel USP, 2%. Read More »
Gilteritinib gains orphan-drug status to combat AML
Because acute myeloid leukemia (AML) impacts relatively few individuals nationwide, gilteritinib — an anti-cancer medication developed by Tokyo-based Astellas Pharma Inc. — recently attained orphan-drug designation from the U.S. Food and Drug Administration. Read More »
Eisai's supplemental application for Fycompa CIII accepted
Eisai Inc.'s supplemental New Drug Application for Fycompa CIII has been accepted by the U.S. Food and Drug Administration. Read More »
Alerts Sign-up