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Horizon Pharma plc Receives European Commission Approval for RAVICTI(R) (glycerol phenylbutyrate) Oral Liquid for the Treatment of Urea Cycle Disorders in Patients Two Months of Age and Older

Pediatric ApprovalHorizon Pharma2015-12-02 09:23 Read   321

Horizon Therapeutics Limited, today announced that the European Commission (EC) has adopted a binding decision to approve RAVICTI® (glycerol phenylbutyrate) Oral Liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients two months of age and older with six subtypes of Urea Cycle Disorders (UCDs).

FDA approves Empliciti, a new immune-stimulating therapy to treat multiple myeloma

CombinationFDA2015-12-01 09:41 Read   392

FDA granted approval for Empliciti (elotuzumab) in combination with two other therapies to treat people with multiple myeloma who have received one to three prior medications.

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

Pfizer Receives European Approval to Expand Use of XALKORI® (crizotinib) to First-Line Treatment of Adults with ALK-Positive Advanced Non-Small Cell Lung Cancer

ExpansionPfizer2015-11-26 13:50 Read   387

 Pfizer today announced that the European Commission has approved a label update to expand use of XALKORI® (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Impax Receives European Commission Marketing Authorization for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's Disease

MarketImpax2015-11-26 10:34 Read   568

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease.

Roche receives EU approval of Cotellic for use in combination with Zelboraf in advanced melanoma

CombinationRoche2015-11-26 09:23 Read   466

Roche announced today that the European Commission has approved CotellicTM (cobimetinib) for use in combination with Zelboraf® (vemurafenib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

European Commission Approves Amgen's BLINCYTO® (blinatumomab) for the Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia

MarketAmgen2015-11-25 16:05 Read   424

Amgen today announced that the European Commission (EC) has granted conditional marketing authorization for BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

Novartis' heart failure medicine Entresto(TM) receives EU approval

NCE ApprovalNovartis2015-11-25 13:33 Read   461

Novartis announced today that the European Commission (EC) has approved EntrestoTM (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF).

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.

European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

MarketGilead2015-11-24 17:14 Read   1673

Gilead’s First TAF-based Single Tablet Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens

FDA Approves Pradaxa® (dabigatran etexilate mesylate) for Prophylaxis of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) after Hip Replacement Surgery

IndicationBoehringer Ingelheim 2015-11-24 16:48 Read   316

Approval based on phase III trial data demonstrating the safety and efficacy of PRADAXA compared to enoxaparin. Provides new therapeutic option to the thousands of Americans at risk for DVT and PE after hip replacement surgery