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Amgen's Repatha® (Evolocumab) Approved As First PCSK9 Inhibitor In Japan For The Treatment Of High Cholesterol

BLA ApprovalAmgen2016-01-26 08:30 Read   641

Important Milestone for Certain Japanese Patients With Uncontrolled LDL Cholesterol First Approval for Amgen and Astellas Joint Venture

U.S. FDA Approves BOTOX® (onabotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults

BLA ApprovalAllergan2016-01-26 08:30 Read   123

BOTOX is the First and Only FDA-Approved Neurotoxin Treatment for Both Upper and Lower Limb Spasticity

European Commission Approves Label Variation for ADCETRIS® (Brentuximab Vedotin) to Include Data on Retreatment of Adult Patients with Relapsed or Refractory Hodgkin Lymphoma and Systemic Anaplastic Large Cell Lymphoma (sALCL)

BLA ApprovalTakeda2016-01-25 09:55 Read   124

European Commission Approves Label Variation for ADCETRIS(Brentuximab Vedotin) to Include Data on Retreatment of Adult Patients with Relapsed or Refractory Hodgkin Lymphoma and Systemic Anaplastic Large Cell Lymphoma (sALCL)

Genmab Announces U.S. FDA Approval of Arzerra® (ofatumumab) as Extended Treatment for Recurrent or Progressive CLL

BLA ApprovalGenmab2016-01-22 08:55 Read   194

Genmab announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for the use of Arzerra® (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).

Biotest receives approval in the European Union for the early use of Zutectra® after liver transplantation

BLA ApprovalBiotest 2016-01-13 14:47 Read   238

The European Commission has granted marketing approval to Biotest for the early use of the hepatitis B immunoglobulin Zutectra after liver transplantation.

FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes

BLA ApprovalFDA2015-12-17 13:25 Read   527

The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. 

Praxbind® (idarucizumab) approved in European Union for the specific reversal of Pradaxa® (dabigatran etexilate)

BLA ApprovalBoehringer Ingelheim2015-11-27 11:00 Read   857

Idarucizumab is the first specific reversal agent for a NOAC to receive European approval.Idarucizumab immediately reverses the anticoagulant effect of dabigatran

FDA approves Portrazza to treat advanced squamous non-small cell lung cancer

BLA ApprovalFDA2015-11-25 10:32 Read   333

The U.S. Food and Drug Administration today approved Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.

FDA approves first seasonal influenza vaccine containing an adjuvant

BLA ApprovalFDA2015-11-25 09:34 Read   757

The U.S. Food and Drug Administration today approved Fluad, the first seasonal influenza vaccine containing an adjuvant.

FDA approves Opdivo to treat advanced form of kidney cancer

BLA ApprovalFDA2015-11-24 09:42 Read   252

The U.S. FDA today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.

FDA approves Ninlaro, new oral medication to treat multiple myeloma

BLA ApprovalFDA2015-11-21 21:07 Read   395

Today the U.S. Food and Drug Administration granted approval for Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy.

European Medicines Agency approves Xiapex® for concurrent treatment of palpable cords

BLA ApprovalSobi2015-11-18 11:09 Read   334

Sobi today announced that the EMA has approved Xiapex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.