FDA grants Breakthrough Therapy designation to Avelumab for treating Merkel cell carcinoma
The US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough…
Pharmaceuticals, Biotechnology and Life Sciences
The US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough…
Anavex is moving forward with the development program for ANAVEX 2-73 for the treatment of Alzheimer’s disease in a…
Steven H. Collis, the President and Chief Executive Officer (CEO) of AmerisourceBergen Corporation will succeed Richard C. Gozon as Chairman of the Board
Hikma’s Portuguese facility back into compliance with the US FDA.
The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF).
Sanofi has appointed Xavier Darcos as President of the Sanofi Espoir Foundation, who succeeds Jean-François Dehecq. Under Dehecq’s Presidency, According to the…
Mylan N.V. has launch Almotriptan Tablets USP, 6.25 mg and 12.5 mg, the generic version of Janssen Pharmaceutical’s AXERT in the U.S.…
Advaxis, a clinical-stage biotechnology company developing cancer immunotherapies, has received preliminary approval for a $1.8 million tax credit from the New Jersey Technology Business Tax Certificate Transfer (NOL) Program for the year 2015.
Amgen will present eight IMLYGIC (talimogene laherparepvec) abstracts, including data from the Phase 3 trial and new data from its Phase 1b combination trial with Merck’s anti-PD-1 therapy, at the 12th International Congress of the Society for Melanoma Research …
Gilead Sciences, Inc. said Monday that its Phase 3 Study 115 evaluating Zydelig (idelalisib) added to standard therapy in previously-treated chronic lymphocytic leukemia (CLL) patients will be unblinded early.