Janssen-Cilag (Janssen), a subsidiary of Johnson & Johnson pharmaceutical firm, has submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of once daily oral drug ibrutinib for the ...
Tags: Blood Cancer Medicine, Medicine
GlaxoSmithKline (GSK) has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA dry powder ...
Tags: Asthma Treatment, Medicine
Amarin, a biopharmaceutical company, has announced the outcome of the US Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee for the use of Vascepa (icosapent ethyl) capsules in the treatment of high ...
AMAG Pharmaceuticals has received a notice of three-month extension from the US Food and Drug Administration (FDA) for a supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection to be used for intravenous (IV) therapy. ...
Tags: AMAG Pharma, Intravenous Use
US-based biopharmaceutical company MannKind has resubmitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking marketing authorization for its AFREZZA inhalation powder, indicated to improve glycemic control ...
Tags: Insulin Application, biopharmaceutical company MannKind
InSite Vision Incorporated (INSV) has reported that the US District Court for the District of New Jersey upheld all four of the patents protecting AzaSite, an azithromycin 1% ophthalmic solution, in a patent infringement lawsuit against ...
US-based specialty pharmaceutical firm Par Pharmaceutical has received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for clonidine hydrochloride (HCl) extended-release (ER) ...
Tags: Par Pharmaceutical, Medicine
US-based clinical stage biopharmaceutical firm Heat Biologics has filed an investigational new drug application (NDA) with the US Food and Drug Administration (FDA) for its second product candidate, HS-410, which will be evaluated in ...
Mylan Pharmaceuticals, a subsidiary of Mylan, has introduced Voriconazole for oral suspension, 40 mg/mL, which is the first generic version of Pfizer's VFEND for oral suspension. The US Food and Drug Administration (FDA) has granted a ...
Tags: Mylan, Antifungal Drug
Bayer HealthCare Pharmaceuticals, a subsidiary of Bayer, has obtained two separate orphan drug designations from the US Food and Drug Administration's (FDA) Office of Orphan Products Development for its investigational, oral medication ...
Tags: Drug Designations, Medicine
The US Food and Drug Administration (FDA) has accepted to review AstraZeneca's new drug application (NDA) for Epanova, an investigational compound for the treatment for patients with severe hypertriglyceridaemia. Omthera Pharmaceuticals, ...
US-based Avanir Pharmaceuticals (AVNR) has entered into a settlement agreement with the US unit of Indian drugmaker Wockhardt to resolve pending patent litigation in response to Wockhardt's abbreviated new drug application (ANDA) seeking ...
Tags: Avanir Pharma, Medicine
The US Food and Drug Administration (FDA) has scheduled a meeting on 03 October 2013 to discuss QRxPharma's Moxduo new drug application (NDA) for the treatment of moderate to severe acute pain. The meeting is aimed at focusing on ...
Tags: Acute Pain Drug
The US Food and Drug Administration (FDA) has accepted for review the complete response submission made by Endo Health Solutions' subsidiary Endo Pharmaceuticals to the new drug application (NDA) for its testosterone undecanoate injection ...
Tags: Aveed Injection, Medicine
Clinical-stage biopharmaceutical company Pharmacyclics' new drug application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor, ibrutinib, has been accepted by the US FDA for two B-cell malignancy indications. ...
Tags: Solvay Group, Medicine