Approvals

Sensorion receives FDA IND approval for Arazasetron

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.

FDA approves Grifols’ Xembify to treat primary immunodeficiencies

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.

FDA approves new treatment for refractory multiple myeloma

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.

Pfizer gets FDA nod for Avastin’s biosimilar Zirabev

Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Zirabev (bevacizumab-bvzr), an oncology biosimilar to Roche’s Avastin (bevacizumab).

FDA approves Alexion’s Soliris to treat adults with neuromyelitis optica spectrum disorder

Alexion Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for Soliris to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive.

FDA grants fast track designation to empagliflozin to treat chronic heart failure

The US Food and Drug Administration (FDA) has granted fast track designation to empagliflozin for the reduction of the risk of cardiovascular death and hospitalization for heart failure in people with chronic heart failure, Boehringer Ingelheim and Eli Lilly and Company announced.

Regeneron, Sanofi get FDA nod for Dupixent to treat chronic rhinosinusitis with nasal polyps

Regeneron Pharmaceuticals and Sanofi have secured approval from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) to treat adults with nasal polyps accompanied by chronic rhinosinusitis.

Pfizer’s Talzenna gets EC nod for metastatic breast cancer treatment

Pfizer has secured approval from the European Commission (EC) for its Talzenna (talazoparib) to treat patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (MBC).

Allergan’s Botox secures FDA paediatric approval for upper limb spasticity

The US Food and Drug Administration (FDA) has expanded the approval of Allergan’s Botox (onabotulinumtoxinA) to cover the treatment of paediatric patients with upper limb spasticity.