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EU approval for Revolade for children with rare blood disorder

Indicationpharmatimes2016-04-11 10:37 Read   187

The European Commission has approved Novartis’ Revolade (eltrombopag) as a first-in-class therapy for children aged one and over with chronic idiopathic thrombocytopenic purpura (ITP) that have not responded to other treatments.

European Commission Approves Bristol-Myers Squibb’s Opdivo® (nivolumab) for Previously Treated Advanced Renal Cell Carcinoma

IndicationBristol-Myers Squibb Company2016-04-08 16:51 Read   228

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved Opdivo (nivolumab) monotherapy for an additional indication in advanced renal cell carcinoma (RCC) after prior therapy in adults.

European Commission Approves Expanded Use of Opdivo® (nivolumab) to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer

IndicationBristol-Myers Squibb Company2016-04-08 16:38 Read   186

This approval expands Opdivo’s existing lung cancer indication in previously treated metastatic squamous NSCLC to include the non-squamous patient population, which together represents 85% of lung cancer cases

Novartis receives EU approval for Revolade® as first-in-class therapy for children aged 1 year and above with chronic ITP

IndicationNovartis2016-04-08 13:51 Read   471

Novartis announced today that the European Commission (EC) has approved Revolade® (eltrombopag) for the treatment of pediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).

Giotrif® (afatinib) approved in Europe as new oral treatment option for patients with squamous cell carcinoma of the lung

IndicationBoehringer Ingelheim2016-04-08 13:36 Read   207

Boehringer Ingelheim today announced that the European Commission (EC) has granted marketing authorisation for Giotrif® (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy.

FDA expands use of Xalkori to treat rare form of advanced non-small cell lung cancer

IndicationFDA2016-03-14 09:34 Read   151

The U.S. FDA today approved Xalkori (crizotinib) to treat people with advanced (metastatic) non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration.

U.S. FDA Approves IMBRUVICA® (ibrutinib) for First-line Treatment of Chronic Lymphocytic Leukemia

IndicationJanssen2016-03-07 10:43 Read   184

The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) capsules for treatment-naïve patients with chronic lymphocytic leukemia (CLL).

FDA Approves New Indication for FASLODEX® (fulvestrant)

IndicationAstraZeneca2016-03-04 11:05 Read   154

AstraZeneca today announced that the US FDA has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib.

FDA approves new indication for Novartis drug Afinitor® for progressive, nonfunctional GI and lung neuroendocrine tumors (NET)

IndicationNovartis2016-02-29 10:49 Read   246

Novartis today announced that the United States FDA approved Afinitor® (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.

FDA Approves Genentech’s Gazyva (Obinutuzumab) for Certain People with Previously Treated Follicular Lymphoma

IndicationGenentech2016-02-29 09:48 Read   217

Genentech today announced that the U.S. FDA approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan® (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment.

U.S. FDA Approves Two Supplemental Indications for Harvoni® in Chronic Hepatitis C Patients With Advanced Liver Disease

Indication Gilead Sciences2016-02-17 10:07 Read   170

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease.

U.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C

IndicationBristol-Myers Squibb Company2016-02-09 15:59 Read   244

Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3.