Approvals

Celgene gets FDA approval for Otezla to treat oral ulcers associated with Behçet’s Disease

Celgene has secured approval from the US Food and Drug Administration (FDA) for its Otezla (apremilast) 30mg twice daily (BID) to treat adult patients with oral ulcers associated with Behçet’s Disease.

LifeMax receives rare pediatric disease designation for LM-030 to treat Netherton Syndrome

LifeMax Laboratories, a private company focused on treating rare diseases with few or no therapeutic options, announced that the Food & Drug Administration (FDA) granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.

FDA approves Merck’s Recarbrio to treat complicated infections

Merck has secured approval from the US Food and Drug Administration (FDA) for its Recarbrio (imipenem, cilastatin and relebactam) to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Dicerna gets breakthrough therapy designation for DCR-PHXC to treat primary hyperoxaluria type 1

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 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.