Regulation

Novelion’s Myalepta gets European approval to treat generalized and partial lipodystrophy

Novelion Therapeutics has secured marketing authorization from the European Commission (EC) for Myalepta (metreleptin) to treat generalized and partial lipodystrophy.

Progenics’ Azedra gets FDA approval for rare adrenal gland tumors

Progenics Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its radiotherapeutic drug Azedra (iobenguane I 131) to treat rare tumors of the adrenal gland (pheochromocytoma or paraganglioma).

CHMP adopts positive opinion for AstraZeneca’s Imfinzi for NSCLC

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted positive opinion for the approval of AstraZeneca’s Imfinzi (durvalumab) for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumors express PD-L1 on ≥1% of tumor cells and whose disease has not progressed after platinum-based chemotherapy and radiation therapy (CRT).

European Commission grants marketing authorization for Sandoz’ biosimilar Hyrimoz

Novartis division Sandoz has secured marketing authorization from the European Commission (EC) for its biosimilar Hyrimoz (adalimumab) for use in all same indications as reference medicine including rheumatology, gastroenterology and dermatology.

FDA approves Perseris for extended-release injectable suspension to treat schizophrenia in adults

Indivior announced that the US Food and Drug Administration (FDA) has approved Perseris, the first once-monthly subcutaneous risperidone-containing, long-acting injectable (LAI) for the treatment of schizophrenia in adults.

FDA advisory committee votes against approving GSK’s mepolizumab to treat COPD

The Pulmonary Allergy Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending GlaxoSmithKline’s (GSK) mepolizumab as an add-on treatment to inhaled corticosteroid-based maintenance treatment to reduce exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

Agios Pharmaceuticals secures FDA nod for leukemia treatment Tibsovo

Agios Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for its Tibsovo (ivosidenib) to treat adult patients with relapsed or refractory acute myeloid leukemia (R/R AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation.

Indivior wins US court order blocking Dr. Reddy’s sale of generic opioid treatment

A US court has approved Indivior’s preliminary injunction (PI) preventing Dr. Reddy's Laboratories (DRL) from marketing of generic opioid addiction treatment.

SIGA Technologies gets FDA nod for TPOXX to treat smallpox

SIGA Technologies has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.