Drug News

Added 15 hours ago Drug news

Valeant Pharmaceuticals International announces marketing information for Siliq (brodalumab), a new treatment for psoriasis.

Valeant Pharmaceuticals International, Inc. announced that following the evaluation and approval of its Patient Access and Pricing Committee (PAPC), the...

Added 1 day ago Drug news

CytRx Corporation agrees on preparations for a New Drug Application (NDA) submission for aldoxorubicin in soft tissue sarcomas (STS).

CytRx Corporation has announced the FDA has reached an agreement with CytRx on preparations for a New Drug Application (NDA)...

Added 1 day ago Drug news

EU CHMP recommends approval of Besponsa (inotuzumab ozogamicin) for treating acute lymphoblastic leukaemia- Pfizer

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation...

Added 2 days ago Drug news

Amgen files sBLA with FDA and application for variation of MAA with EMA for Xgeva (denosumab) to prevent skeletal-related events (SREs) in solid tumors to include patients with multiple myeloma.-Amgen

Amgen has announced the submission of a supplemental Biologics License Application (sBLA) to the FDA and an application for a...

Added 2 days ago Drug news

Complete Response letter for CCP 07 a cough cold treatment being developed for Vernalis plc by partner Tris Pharma.

Vernalis plc announces that the FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for...

Added 2 days ago Drug news

EU CHMP recommends approval of Brineura (cerliponase alfa) for Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) disease- BioMarin

The Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted...

Added 2 days ago Drug news

Real world study of Zepatier (elbasvir + grazoprevir) shows benefits in hepatitis C- Merck Inc

Merck Inc announced the presentation of findings from a retrospective database analysis of patients with chronic hepatitis C virus (HCV)...

Added 2 days ago Drug news

uniQure N.V. announced that it will not pursue the renewal of the Glybera(alipogene tiparvovec) marketing authorization in Europe when it is scheduled to expire on October 25, 2017.

uniQure N.V. announced that it will not pursue the renewal of the Glybera(alipogene tiparvovec) marketing authorization in Europe when it...

Added 2 days ago Drug news

EU CHMP recommends approval of Opdivo (nivolumab) in bladder cancer- BMS

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo...

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