Imprimis Pharmaceuticals responds to FDA MedWatch notice
Imprimis Pharmaceuticals Inc. recently released a statement after the MedWatch notification put forth by the U.S. Food and Drug Administration. Read More »
FDA approves AbbVie's HCV infection drug Mavyret
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 initiates EAP for investigation drug
La Jolla Pharmaceutical Co. recently initiated an expanded access program (EAP) in the United States for its investigational drug LJPC-501. Read More »
FDA grants Breakthrough Therapy Designation to lymphoma drug
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's psoriatic arthritis treatment clears advisory committee
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 »
FDA grants interim approval for Mylan’s TLD formulation
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 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 »
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