AbbVie’s Skyrizifor received EC approval to treat adults with active psoriatic arthritis
AbbVie announced that the European Commission (EC) has approved Skyrizi (risankizumab, 150 mg, subcutaneous injection at week 0, week 4 and every... Read More
Corbus Pharma in-licenses two integrin targeting MAbs
US biotech Corbus Pharmaceuticals (Nasdaq: CRBP) today announced the expansion of its portfolio into immuno-oncology through licensing deals for two new monoclonal... Read More
Case Study – Inmazeb: USFDA Approval of first ebola medicine
U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a combination of three monoclonal antibodies, as the first FDA-approved treatment... Read More
AbbVie’s Elezanumab receives US FDA orphan drug and fast track designations
Posted on30 Sep 2020
Comments0
AbbVie announced that the US Food and Drug Administration (FDA) has granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an... Read More
Pfizer launched Zirabev, Ruxience, Trazimera biosimilar in US
Posted on29 Jan 2020
TagsBevacizumab, Biosimilar, MAB, monoclonal antibody, pfizer, Rituximab, Ruxience, trastuzumab, Trazimera, Zirabev
Comments0
Pfizer has launched three biosimilars in the U.S. market. Pfizer has priced these biosimilars aggressively to get quick market share. Zirabev Biosimilar... Read More
US FDA issues Complete Response Lette to Takeda’s Entyvio for maintenance therapy in adults with ulcerative colitis
Takeda Pharmaceutical Company Limited received a Complete Response Letter from the US Food and Drug Administration (FDA) in response to the submission... Read More
Sandoz to commercialize proposed multiple sclerosis biosimilar natalizumab
Sandoz, a Novartis division and a global leader in biosimilars, announced that it has entered into a global commercialization agreement for a... Read More
US FDA grants priority review status to Novartis’ sickle cell molecule crizanlizumab
Posted on17 Jul 2019
Tagscrizanlizumab, MAB, monoclonal antibody, priority review, Priority Review Designation, USFDA Priority Review
Comments0
Novartis announced the US Food and Drug Administration (FDA) accepted the company’s Biologics License Application (BLA) and has granted Priority Review for... Read More
Case Study: EC’s conditional marketing approval to Libtayo for advanced CSCC
Posted on02 Jul 2019
Tagscemiplimab, Conditional marketing authorisation, EU marketing authorization, Libtayo, MAB, Regeneron, Sanofi
Comments0
The European Commission (EC) has granted conditional marketing authorization for Libtayo (cemiplimab) for the treatment of adults with metastatic or locally advanced... Read More
USFDA Approves Amgen’s Trastuzumab Biosimilar, Kanjinti
The FDA has approved Amgen’s ABP 980, a trastuzumab biosimilar referencing Herceptin. The drug, trastuzumab-anns, will be sold as Kanjinti. Kanjinti was approved for... Read More