India’s Aurobindo gets USFDA’s OK for its pulmonary tablets ‘Sildenafil’
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil…
Pharmaceuticals, Biotechnology and Life Sciences
Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Sildenafil…
The European Commission (EC) has approved Novartis’ Cosentyx (secukinumab) for the treatment of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA). For AS.
Bayer has submitted an application for marketing authorization in both the European Union and in the United States for LCS-16, a new low-dose levonorgestrel-releasing intrauterine system
Judge Peter Kirwan of the Superior Court of California for the County of Santa Clara has granted Depomed motion for…
The U.S. Food and Drug Administration approved Narcan nasal spray on Wednesday. Narcan is the first FDA-approved nasal spray version of…
Health Canada has accepted for review Janssen’s new drug submission (NDS) for daratumumab for treatment of Multiple Myeloma.
Amgen’s new injectable cholesterol drug Repatha has been turned down for use on Britain’s state health service, underscoring a worldwide debate about the value of such pricey medicines.
The US Food and Drug Administration (FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough…
The European Commission has approved expansion of the indication for Vertex Pharmaceuticals’ Kalydeco, to include children ages 2-5 with cystic fibrosis…
The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Neulasta (pegfilgrastim) – a recombinant human granulocyte colony-stimulating factor (G-CSF).