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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)

Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE® (dalbavancin)

RouteAllergan2016-01-24 08:22 Read   195

Single-Dose Option Approved for Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

U.S. Food and Drug Administration Approves Humulin® R U-500 KwikPen

RouteEli Lilly2016-01-23 09:30 Read   187

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's (NYSE: LLY) Humulin®R U-500 KwikPen®(insulin human injection) 500 units/mL, a pre-filled device containing Humulin R U-500, a highly concentrated formulation of insulin. Humulin R U-500 is the only FDA-approved insulin that is five-times more concentrated than standard U-100 insulin.

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).

UCB’s new epilepsy drug BRIVIACT® receives EU approval

NCE ApprovalUCB2016-01-21 08:41 Read   240

UCB today announced the European Commission (EC) has approved BRIVIACT® (brivaracetam) as an adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization (spreading to both sides of the brain after the initial seizure) in adult and adolescent patients from 16 years of age with epilepsy.

Baxalta Granted EU Marketing Authorization for ONCASPAR (pegaspargase) as a Component of Combination Therapy in Acute Lymphoblastic Leukaemia (ALL)

MarketBaxalta2016-01-20 09:47 Read   358

EU Marketing Authorization offers the potential for broader access to ONCASPAR as Baxalta continues to build its innovative and diverse portfolio of differentiated oncology treatments

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 Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers

IndicationFDA2016-01-08 10:10 Read   330

The U.S. Food and Drug Administration today approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides an environment for new skin and tissue to regenerate and heal the wound.

Eagle Pharmaceuticals Announces FDA Approval of Docetaxel Injection, Non-Alcohol Formula

RouteEagle Pharmaceuticals2015-12-26 20:32 Read   355

Eagle Pharmaceuticals, Inc. announced today that FDA has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Merz North America Announces FDA Approval Of XEOMIN® (incobotulinumtoxinA) For Treatment of Adult Upper Limb Spasticity

IndicationMerz2015-12-25 13:14 Read   156

Merz North America, U.S. affiliate of the global Merz Pharma Group, announces that Xeomin® (incobotulinumtoxinA) has received U.S. FDA approval for the treatment of upper limb spasticity (ULS) in adult patients.