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European Commission Grants Marketing Authorization for Gilead’s Fixed-Dose Combination Descovy® (Emtricitabine, Tenofovir Alafenamide) for Treatment of HIV

Combinationpipeline review2016-04-26 17:34 Read   278

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission has granted marketing authorization for two doses of Descovy® (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF), a fixed-dose combination for the treatment of HIV-1 infection.

FDA Approves Descovy

CombinationGilead Sciences2016-04-05 14:09 Read   147

FDA Approves Descovy (emtricitabine and tenofovir alafenamide), Gilead’s Third TAF-Based HIV Therapy

LEO Pharma Receives Scientific Approval of Enstilar® for the Treatment of Psoriasis in EU

CombinationLEO Pharma2016-03-22 10:43 Read   704

The marketing approval of Enstilar® would make it the first fixed combination topical foam treatment for people living with psoriasis vulgaris in the EU.

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

CombinationFDA2016-01-29 10:15 Read   227

The U.S. FDA today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients.

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.

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.

FDA Approves COTELLIC™ (Cobimetinib) for use in Combination with Vemurafenib to Treat Advanced Melanoma

CombinationExelixis2015-11-11 13:15 Read   494

Exelixis, Inc.today announced that FDA has approved COTELLIC™ (cobimetinib) as a treatment for patients with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib.

U.S. Food and Drug Administration Approves New Treatment Combination of Gilead’s Letairis® with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1)

CombinationPharmacodia.com2015-10-04 00:00 Read   616

First-Line Combination of Letairis and Tadalafil Reduced Risk of Disease Progression by Nearly 50 Percent Compared to Either Therapy Individually in Study of 605 PAH Patients with WHO Functional Class II-III Symptoms.

Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

CombinationPharmacodia.com2015-10-02 00:00 Read   945

USA October 1, 2015, Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Today’s announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

FDA approves new oral medication to treat patients with advanced colorectal cancer

CombinationPharmacodia.com2015-09-23 00:00 Read   512

The U.S. Food and Drug Administration approved Lonsurf (a pill that combines two drugs, trifluridine and tipiracil) for patients with an advanced form of colorectal cancer who are no longer responding to other therapies in Sep 22, 2015.

U.S. FDA approved Technivie (ombitasvir/paritaprevir/ritonavir) in combination with ribavirin for the treatment of HCV genotype 4 infections without cirrhosis.

CombinationPharmacodia.com2015-07-24 00:00 Read   459

On July 24, 2015, U.S. FDA approved Technivie (ombitasvir/paritaprevir/ritonavir) in combination with ribavirin (RBV) for the treatment of genotype 4 (GT4) HCV infection without cirrhosis. Technivie is the first and only all-oral, interferon-free, direct-acting antiviral treatment approved in the U.S. for adult patients with GT4 chronic HCV infection.

U.S.FDA approved Entresto (sacubitril/valsartan) to treat heart failure

CombinationPharmacodia.com2015-07-07 00:00 Read   358

On July 7, 2015, FDA approved Entresto（sacubitril/valsartan）to treat heart failure. It is a condition in which the heart can‘t pump enough blood to meet the body‘s needs. Entresto (LCZ696) has been shown to reduce the rate of cardiovascular death and hospitalization related to heart failure. It is expected to become a blockbuster product.