Pharma News

The FDA has expanded its approval of Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) between the ages of 12 and 24 months who are homozygous f...

The FDA has granted expanded approval for AstraZeneca’s blockbuster drug Imfinzi (durvalumab) in combination with chemotherapy gemcitabine and cisplatin to treat adults with locally advanced or ...

Small cell lung cancer (SCLC) is one of the deadliest forms of the disease, but now scientists may have a promising new avenue for treatment. 

Amneal Pharmaceuticals has submitted a New Drug Application (NDA) to the FDA for its investigational candidate IPX203 for the treatment of patients with Parkinson’s disease. ...

MZE001 is being assessed in a Phase I trial to evaluate the tolerability, safety, pharmacokinetics and pharmacodynamics.

The FDA has approved Boehringer Ingelheim's Spevigo (spesolimab) for generalized pustular psoriasis (GPP) flares in adults, making it the first drug approved for this indication. ...

Amneal Pharmaceuticals has filed for FDA approval of an extended-release Parkinson’s disease prospect that is tipped to deliver peak U.S. sales of up to $500 million. ...

Research indicates that there is a growing amount of unusual hepatitis cases in children throughout Europe.

Merck’s investigational anticoagulant therapy MK-2060 has received Fast Track designation from the FDA for reducing the risk of major thrombotic cardiovascular events in patients with end-stage r...

The long-awaited review of problematic opioid prescribing is taking longer than observers had hoped. Studies of this extended use of the pain medications have lagged for years beyond their expected...

The European Commission (EC) has granted marketing authorization to Ranivisio (ranibizumab), a biosimilar of Genentech and Novartis’ Lucentis, for treatment of several retinal diseases. ...

Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare geneti...