Alembic Pharmaceuticals has secured tentative approval for the abbreviated new drug application (ANDA) of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg from the US Food and Drug Administration (FDA). The tentatively approved product is the generic of Bristol Myers Squibb Company’s Sprycel Tablets, 20 mg, 50 mg, […]
Rylaze FDA approval : Jazz Pharmaceuticals has secured approval for its leukemia drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn or JZP458) from the US Food and Drug Administration (FDA). The Irish biopharma company bagged the approval for the drug to be used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic […]
In a significant development for pediatric oncology, the European Commission (EC) has approved an expanded indication for Amgen’s BLINCYTO (blinatumomab) as a monotherapy treatment for certain types of acute lymphoblastic leukemia (ALL) in children aged one year and older. This approval marks a crucial advancement in the treatment options available for this challenging medical condition. […]
Pfizer Inc. has received a priority review designation from the U.S. Food and Drug Administration (FDA) for its innovative blood cancer drug, inotuzumab ozogamicin. This critical status will expedite the review process, potentially bringing this new treatment option to patients with acute lymphoblastic leukemia (ALL) sooner. FDA Priority Review Accelerates Approval Process Inotuzumab ozogamicin, an […]