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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.

EU green light for Lilly's lung cancer drug Portrazza

BLA ApprovalLilly2016-02-27 12:45 Read   163

European regulators have approved Eli Lilly’s Portrazza as a treatment for patients with advanced non-small cell lung cancer (NSCLC).

Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis

DosagePfizer2016-02-26 09:29 Read   811

Pfizer Inc. (NYSE:PFE) announced today that the U.S. FDA has approved XELJANZ® XR extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).

FibCLOT®, Human Fibrinogen from LFB, Obtains First Marketing Authorisations in Europe

BLA Approval LFB SA2016-02-24 14:13 Read   263

LFB SA announces it has obtained the first three European marketing authorisations for its human fibrinogen, in Germany, Denmark and Hungary, via a decentralised licensing procedure. Thirteen more marketing authorisations are expected in Europe in the coming months.

Bayer's new haemophilia A drug cleared in Europe

BLA ApprovalBayer2016-02-23 16:55 Read   157

European patients with the haemophilia A could soon get access to a new treatment option after regulators approved Bayer’s Kovaltry for all age groups.

Pfizer Receives Expanded FDA Approval For IBRANCE (palbociclib) In HR+, HER2- Metastatic Breast Cancer

ExpansionPfizer2016-02-23 13:46 Read   162

Pfizer Inc. today announced that the U.S. FDA has approved a new indication expanding the use of IBRANCE® (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy.

Brilique (ticagrelor) approved in EU for extended treatment of patients with history of heart attack

DosageAstraZeneca2016-02-23 10:53 Read   572

AstraZeneca today announced that the European Commission has granted marketing authorisation for Brilique (ticagrelor) at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.

Zurampic (lesinurad) approved in the European Union for patients with gout

NCE ApprovalAstraZeneca2016-02-23 09:57 Read   229

AstraZeneca today announced that the European Commission (EC) has granted marketing authorisation for Zurampic (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.

FDA approves Briviact to treat partial onset seizures

NCE ApprovalFDA2016-02-22 09:35 Read   174

The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.

Biocon gets approval for generic Crestor in Europe

MarketBiocon2016-02-18 10:51 Read   162

Biopharmaceuticals firm Biocon Ltd on Monday said it has got approval to sell the generic equivalent of Astrazenaca Plc’s cholesterol-lowering pill Crestor in the European Union (EU).

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.