1,636 Results

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

 Added 1 day ago

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

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

 Added 1 day ago

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

Phase III study of dasotraline shows significant improvement in children with ADHD- Sunovion Pharma

 Added 2 days ago

Sunovion Pharmaceuticals announced positive results of a pivotal Phase III study (SEP360-305) evaluating the efficacy and safety of dasotraline being...

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

 Added 2 days ago

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

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

 Added 2 days ago

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

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

 Added 2 days ago

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

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

 Added 2 days ago

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

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.

 Added 2 days ago

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

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

 Added 2 days ago

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