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.
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.
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 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.
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 has secured approval from the US Food and Drug Administration (FDA) for its TPOXX (tecovirimat) for the treatment of smallpox.
The European Medicines Agency (EMA) has recalled certain heart drugs containing valsartan across the European Union (EU) over possible contamination with a cancer-causing substance.
Alliance Pharma has secured approval for Diclectin in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of nausea and vomiting in pregnant women.
The European Medicines Agency (EMA) has accepted Clovis Oncology’s marketing application for a new indication of Rubraca (rucaparib) as maintenance treatment for women with recurrent ovarian cancer.
AstraZeneca has secured regulatory approvals for two major cancer drugs, Imfinzi and Lynparza, in Japan.
Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.