Gilead Sciences has announced that the US Food and Drug Administration (FDA) has approved Sovaldi (sofosbuvir) 400mg tablets, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection ...
Tags: Gilead Sciences, Chronic Hepatitis
Teva Pharmaceutical has licensed rights to commercialize glatiramer acetate to Takeda Pharmaceutical in Japan as part of their agreement signed earlier in 2013. Currently both the firms are working on additional agreements for ...
Tags: Teva Licenses, Medicine
BioDelivery Sciences International (BSDI) announced that it engaged in a positive meeting with the US Food and Drug Administration (FDA) regarding the clinical development program for Clonidine topical gel that will allow the program to ...
QRxPharma, an Australian-based commercial-stage specialty pharmaceutical company, has resubmitted its MOXDUO new drug application (NDA). At a meeting in early October 2013, the US Food and Drug Administration (FDA) provided QRxPharma with ...
Tags: QRxPharma, Drug Application
The US Food and Drug Administration (FDA) has accepted AstraZeneca's new drug application (NDA) for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist (PAMORA). The drug has been studied in opioid-induced ...
Tags: Drug Application, FDA Approval
Merck has secured priority review status from the US Food and Drug Administration (FDA) for its new drug application (NDA) for an investigational intravenous (IV) solution formulation of its antifungal agent, Noxafil (posaconazole), ...
Johnson & Johnson (JNJ) subsidiary Janssen Biotech and Pharmacyclics (PCYC) have won approval from the US Food and Drug Administration (FDA) for their breakthrough therapy Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma ...
Tags: Johnson&Johnson, MCL Patients
The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection. In the US, Gattex is ...
Tags: FDA, biopharmaceutical
NanoViricides has secured orphan drug designation from the European Medicines Agency (EMA) for its drug candidate DengueCide, for the treatment of dengue and dengue hemorrhagic fever. Dengue fever is a mosquito-borne disease that affects ...
Tags: Nanoviricides Drug
A.P. Pharma, a specialty pharmaceutical company, has initiated a program to expand its pipeline of sustained release products, including a new program targeting the relief of post-surgical pain. The company also announced it will pursue a ...
Tags: A.P.Pharma, Pipeline Expansion
Canadian biopharmaceutical firm Aeterna Zentaris has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its ghrelin agonist, macimorelin acetate (AEZS-130), a novel orally-active small molecule. The ...
Tags: Aeterna Zentaris, Medicine
US-based pharmaceutical firm Zogenix has entered into a development and option agreement (D&O Agreement) with Altus Formulation (Altus) to develop abuse deterrent formulations of Zohydro ER (hydrocodone bitartrate) extended-release ...
Tags: Zogenix, Zohydro ER
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
Pharmaceutical companyc Food and Drug Administration (FDA) has approved Zohydro ER (hydrocodone bitartrate) extended-release capsules. Zohydro ER is an opioid agonist, extended-release oral formulation of hydrocodone without ...
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