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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 approves first leadless pacemaker to treat heart rhythm disorders

medical appliancesFDA2016-04-07 11:16 Read   151

The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart.

FDA approves Inflectra, a biosimilar to Remicade

GenericFDA2016-04-06 09:14 Read   135

The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA.

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

Bio Products Laboratory Receives European Approval for Coagadex® (Human Coagulation Factor X)

BLA ApprovalBio Products Laboratory2016-04-02 12:37 Read   142

First-ever treatment for rare bleeding disorder ‘hereditary factor X deficiency’ approved in Europe

Bayer Receives Approval for Kovaltry® for the Treatment of Hemophilia A in Japan

BLA ApprovalBayer2016-03-31 11:02 Read   143

Bayer has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Kovaltry®, a full-length unmodified, recombinant factor VIII product for the treatment of hemophilia A.

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.

FDA Approved 3D Printed Drug Available In The US

MarketFORBE2016-03-25 08:44 Read   165

A continued step forward in the treatment of epilepsy and the power of 3D printing. According to the Centers for Disease Control (CDC), there were 2.4 million adults living with active epilepsy in 2013. In 2015, the U.S. Food and Drug Administration (FDA) approved Spritam, the first 3D printed prescription drug to treat partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures.

FDA approves Cinqair to treat severe asthma

BLA ApprovalFDA 2016-03-24 09:27 Read   143

The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines.

FDA approves new psoriasis drug Taltz

BLA ApprovalFDA2016-03-23 09:00 Read   143

The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis.