Press Releases

Alexion Pharmaceuticals Inc announced that the EC as granted orphan drug designation (ODD) to ALXN1210, a highly innovative, longer-acting C5 antibody being evaluated in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a debihlitating, ultra-rare, life-threatening...

AbbVie a global biopharmaceutical company announced that the EC approved IMBRUVICA® (ibrutinib) as a first-line treatment option for adult patients with chronic lymphocytic leukemia (CLL), expanding upon the initial EC approval in October 2014 for certain patients with CLL....

Label Now Includes New Data on Use of TEFLARO in Pediatric Patients 2 Months of Age to Less than 18 Years of Age with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) and Community-Acquired Bacterial Pneumonia (CABP). ...

The European Commission (EC) granted marketing authorization in the European Union (EU) for FLIXABI®, an infliximab biosimilar referencing Remicade®i. FLIXABI was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen. FLIXABI is indicated...

AbbVie , Eisai Co Ltd. and its subsidiary EA  Pharma Co Ltd. announced the additional approval for a new dosing regimen of Humira® Pre-filled Syringe 40 mg/0.8 mL for Subcutaneous Injection (generic name: adalimumab , “Humira”). ...

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion, recommending the approval of saxa/dapa (saxagliptin and dapagliflozin) tablets for the treatment of adults with type-2 diabetes....

Gilead Sciences Inc announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Epclusa®. ...