Genmab announced that the US Food and Drug Administration (FDA) has granted priority review to the supplemental biologics license application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib, melphalan and prednisone to treat patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
AstraZeneca has secured approvals for its cancer drug Lynparza (olaparib) and asthma drug Fasenra (benralizumab) from the Japanese Ministry of Health, Labour and Welfare for the treatments of ovarian cancer and bronchial asthma, respectively.
Novartis’ CAR-T cell therapy Kymriah (tisagenlecleucel) has been granted fast-tracked reviews in the US and Europe for the treatment of relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
The European Commission (EC) has granted marketing authorization for Shire’s Adynovi [Antihemophilic Factor (Recombinant), PEGylated], an extended half-life recombinant factor VIII (rFVIII) treatment, for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib), for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been earlier treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
The US Food and Drug Administration's (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) has decided not to recommend the approval of Lipocine's TLANDO.
AstraZeneca has secured approval from the European Commission (EC) for Fasenra (benralizumab) as an add-on maintenance treatment for patients with severe eosinophilic asthma.
Lipocine Inc., a specialty pharmaceutical company, announced that the Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") voted six in favor and thirteen against the benefit/risk profile of TLANDO, the Company's oral testosterone product candidate for testosterone replacement therapy ("TRT") in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
Amgen has secured approval from the US Food and Drug Administration (FDA) for its supplemental biologics license application (sBLA) of XGEVA (denosumab) to expand the currently approved indication to prevent skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Novartis’ drug Promacta (eltrombopag) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for first-line treatment of severe aplastic anemia (SAA).
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