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European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV

IndicationBristol-Myers Squibb2016-02-02 08:35 Read   194

European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV

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.

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.

FDA approves wearable defibrillator for children at risk for sudden cardiac arrest

IndicationFDA2015-12-18 10:07 Read   398

The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.

FDA approves first emergency treatment for overdose of certain types of chemotherapy

IndicationFDA2015-12-14 14:39 Read   423

FDA today approved Vistogard for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

FDA approves new oral therapy to treat ALK-positive lung cancer

IndicationFDA2015-12-12 21:59 Read   378

FDA today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).

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

FDA approves vaccine for use after known or suspected anthrax exposure

IndicationFDA2015-11-24 10:52 Read   349

The U.S. Food and Drug Administration today approved a new indication for BioThrax (Anthrax Vaccine Adsorbed) to prevent disease following suspected or confirmed exposure to Bacillus anthracis, the bacterium that causes anthrax disease.

U.S. FDA Approves New Indications for Harvoni®, Gilead’s Once-Daily Single Tablet Regimen for Chronic Hepatitis C

IndicationGilead2015-11-13 11:17 Read   417

Harvoni – the first and only single-tablet regimen for the treatment of HCV – continues to demonstrate high cure rates and a tolerable side effect profile across a range of patient populations, including those who have historically been considered among the most difficult to cure

Celgene’s VIDAZA® (Azacitidine for Injection) Approved by the European Commission as New Treatment for Elderly Patients with Acute Myeloid Leukaemia

IndicationPipelinereview2015-11-01 15:40 Read   522

Expanded indication brings medicine to greater number of elderly AML patients who are not eligible for haematopoietic stem cell transplantation and have >30% myeloblasts in their bone marrow

FDA approves new treatment for advanced pancreatic cancer

IndicationFDA2015-10-23 09:23 Read   257

The U.S. Food and Drug Administration approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

FDA expands approved use of Opdivo in advanced lung cancer

IndicationPharmacodia.com2015-10-10 00:00 Read   325

The U.S. Food and Drug Administration approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy, Oct 9, 2015.