Amgen has announced that the US Food and Drug administration (FDA) has converted the accelerated approval for its blood cancer treatment Blincyto to a full approval.
Servier has received marketing approval from the European Commission (EC) for Tibsovo (ivosidenib tablets) to treat isocitrate dehydrogenase-1 (IDH1)-mutated acute myeloid leukaemia (AML) and IDH1-mutated cholangiocarcinoma.
The FDA has lifted the clinical holds on bluebird bio’s trials of gene therapies in sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT), an inherited blood disorder.
From new research offering promise for children's cancer to FDA registrations, we track the progress made in the past few weeks in terms of advancing CAR T-cell therapy in a number of markets.
Partner Therapeutics (PTx) has acquired the rights to Sanofi’s FDA-approved human growth factor Leukine along with a dedicated manufacturing plant in Washington state.
Pfizer has resubmitted its antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) for regulatory review almost seven years after withdrawing it from the market.
Roche’s subcutaneous formulation of MabThera is about reducing the treatment burden for patients and not protecting it from impending biosimilar competition, the firm says.
Apricus Biosciences, formerly NexMed, announce preclinical data shows NexACT technology enables rectal delivery of biologics, including human antibodies.
