Novartis has secured priority review status from the US Food and Drug Administration (FDA) for its humanized anti-P-selectin monoclonal antibody crizanlizumab (SEG101) for the prevention of vaso-occlusive crises (VOCs) in patients with sickle cell disease (SCD).
AstraZeneca’s oncology immunotherapy Imfinzi (durvalumab) has been granted orphan drug designation (ODD) for the treatment of small cell lung cancer (SCLC).
Dicerna Pharmaceuticals announced that the US Food and Drug Administration (FDA) has granted a breakthrough Therapy Designation (BTD) to DCR-PHXC for the treatment of patients with primary hyperoxaluria type 1 (PH1).
Sensorion has received the investigational new drug (IND) clearance from the US Food and Drug Administration (FDA) to proceed with SENS-401, based on preclinical data and clinical development plan.
Sanofi said that its biologics license application (BLA) for isatuximab for the treatment of relapsed/refractory multiple myeloma (RRMM) has been accepted for review by the US Food and Drug Administration (FDA).
Plasma-derived medicines producer Grifols has secured approval from the US Food and Drug Administration (FDA) for its Xembify, a new 20% subcutaneous immunoglobulin solution, to treat primary immunodeficiencies.
ViiV Healthcare has secured marketing authorisation from the European Commission (EC) for its Dovato (dolutegravir/lamivudine) to treat HIV-1 infection.
The US Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
Sanofi and Regeneron Pharmaceuticals have been given conditional approval by the European Commission (EC) for their fully-human monoclonal antibody Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.
Puma Biotechnology has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease).
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