Categories

USDA Approves Bristol Myers Squibb’s and bluebird bio’s Abecma (idecabtagene vicleucel), the First Anti-BCMA CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma

Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced that the U.S. Food and Drug Administration (FDA) has approved Abecma (idecabtagene vicleucel; ide-cel) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines […]

Read More No Comments

FDA approves Bristol Myers Squibb’s Onureg® (azacitidine tablets) for Continued Treatment of Acute Myeloid Leukemia

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Onureg® (azacitidine 300 mg tablets, CC-486) for the continued treatment of adult patients with acute myeloid leukemia (AML) who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able […]

Read More No Comments

Bristol Myers Squibb’s Breyanzi approved by FDA

Bristol Myers Squibb today announced that the U.S. Food and Drug Administration (FDA) has approved Breyanzi (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not […]

Read More No Comments

FDA Approves Oncopeptides´ PEPAXTO® (melphalan flufenamide) for Patients with Triple-Class Refractory Multiple Myeloma

Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO),  a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple […]

Read More No Comments

PFIZER’S XALKORI® (CRIZOTINIB) APPROVED BY FDA FOR ALK-POSITIVE ANAPLASTIC LARGE CELL LYMPHOMA IN CHILDREN AND YOUNG ADULTS

Pfizer Inc. (NYSE:PFE) recently announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI® (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. The safety […]

Read More No Comments

U.S. Food and Drug Administration Approves OPDIVO® (nivolumab) in Combination with CABOMETYX® (cabozantinib) as First-line Treatment for Patients with Advanced Renal Cell Carcinoma

Bristol Myers Squibb (NYSE: BMY) today announced that OPDIVO®(nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with CABOMETYX® (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).1 The approval is […]

Read More No Comments

AstraZeneca announces new FDA approval for TAGRISSO®.

The US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. About the FDA Decision The results from the Phase […]

Read More No Comments

Merck announces new FDA approval for KEYTRUDA

KEYTRUDA has received FDA approval, in combination with chemotherapy, for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express programmed death ligand 1 (PD-L1) [combined positive score (CPS ≥10)] as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival. Continued […]

Read More No Comments

FDA approves label expansion for ALUNBRIG® (brigatinib)

Takeda Oncology has announced that the US Food and Drug Administration (FDA) has approved the label expansion for ALUNBRIG® (brigatinib) to include patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are tyrosine kinase inhibitor (TKI)-naive. ALUNBRIG is indicated for the treatment of adult patients with ALK+ metastatic NSCLC as detected by an […]

Read More No Comments

US Food and Drug Administration (FDA) approves a new indication for LYNPARZA® (olaparib)

US Food and Drug Administration (FDA) approved a new indication for LYNPARZA® (olaparib), as a treatment option for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an […]

Read More No Comments