The FDA has given approval for the Abbreviated New Drug Application (ANDA) for acetylcysteine injection, from APP Pharma, indicated to...
Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that the FDA approved Zevtera (ceftobiprole medocaril sodium for injection), for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections (ABSSSI) and for adult and pediatric patients (3 months to less than 18 years old) with community-acquired bacterial pneumonia (CABP)
Mylan N.V. announced that the FDA has approved Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL...
The National Institute for Health and Care Excellence (NICE) has in draft guidance recommended Xiapex (clostridial collagenase for injection) for...
Omeros Corporation announced that the European Commission has granted marketing authorization for Omidria (phenylephrine 1% and ketorolac 0.3% injection) in...
On May 27, 2014, the European Medicines Agency (EMA) accepted Sanofi�s marketing authorization dossier for insulin glargine (rDNA origin) injection...
Novo Nordisk announced FDA approval of FlexPro PenMate, designed for users of Norditropin FlexPro (somatropin injection) 5 mg, 10 mg,...
Genentech has announced that the FDA has approved Lucentis (ranibizumab injection) 0.5 mg for the treatment of patients with myopic...