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Cabozantinib (CABOMETYX)

NCE ApprovalFDA2016-04-26 10:52 Read   149

the U. S. Food and Drug Administration approved cabozantinib (CABOMETYX, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.

FDA approves new drug for chronic lymphocytic leukemia in patients with a specific chromosomal abnormality

NCE ApprovalFDA 2016-04-12 09:53 Read   231

The U.S. FDA today approved Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy.

FDA Approves BromSite

NCE ApprovalDRUGS2016-04-11 10:49 Read   183

Sun Pharma Receives FDA Approval For BromSite (bromfenac ophthalmic solution)

FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow

NCE ApprovalFDA2016-03-31 10:31 Read   180

The U.S. Food and Drug Administration today approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT).

Tagrisso™ (osimertinib) approved in Japan for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer

NCE ApprovalAstraZeneca2016-03-30 10:54 Read   915

AstraZeneca today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Tagrisso (osimertinib, AZD9291) 80mg once-daily tablets for the treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy.

EISAI'S IN-HOUSE DEVELOPED ANTIEPILEPTIC DRUG FYCOMPA® (PERAMPANEL HYDRATE) APPROVED IN JAPAN AS ADJUNCTIVE THERAPY FOR PARTIAL-ONSET AND GENERALIZED TONIC-CLONIC SEIZURES

NCE ApprovalEisai2016-03-30 10:21 Read   128

Eisai Co., Ltd. announced today that its in-house-discovered antiepileptic drug (AED) Fycompa® (perampanel hydrate) has been approved in Japan as an adjunctive therapy for partial-onset seizures (including secondarily generalized seizures) or primary generalized tonic-clonic seizures in patients with epilepsy showing inadequate response to other AEDs.

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.

TAGRISSO™ (osimertinib) approved in EU as first-in-class treatment for patients with EGFR T790M mutation-positive metastatic non-small cell lung cancer

NCE ApprovalAstraZeneca2016-02-04 09:28 Read   583

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

FDA approves first drug to show survival benefit in liposarcoma

NCE ApprovalFDA2016-01-30 08:17 Read   161

The U.S. FDA today approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery (unresectable) or is advanced (metastatic).

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.

FDA approves new orphan drug to treat pulmonary arterial hypertension

NCE ApprovalFDA2015-12-24 10:04 Read   256

FDA approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.