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