Press Releases
Bayer collaborates with U.S. National Surgical Adjuvant Breast and Bowel Project to Investigate Stivarga as Adjuvant Therapy in Colon Cancer
Study will include patients with Stage IIIB and IIIC colon cancer who have undergone complete surgical resection of primary tumor and received standard adjuvant chemotherapy / Indication-seeking trial will be conducted by NSABP with the support from Bayer. ...
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Allergan receives US FDA marketing approval for Juvederm Volbella XC for use in lips & perioral rhytids
Allergan plc a leading global pharmaceutical company announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market JUVÉDERM VOLBELLA®XC, for use in the lips for lip augmentation and for correction of perioral...
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Alexion Pharma (ALXN) Granted Ophand Drug Status in Europe for ALXN1210
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...
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EC Approves the AbbVies IMBRUVICA for First-Line Treatment of Patients with Chronic Lymphocytic Leukemia
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....
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Allergan Receives FDA Approval of TEFLARO for Pediatric Patients
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). ...
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EU Grants Approval to Remicade Biosimilar Flixabi
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...
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AbbVie, Eisai and EA Pharma receive additional approval for new Humira dosing regimen
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”). ...
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