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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.

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).

Baxalta Granted EU Marketing Authorization for ONCASPAR (pegaspargase) as a Component of Combination Therapy in Acute Lymphoblastic Leukaemia (ALL)

MarketBaxalta2016-01-20 09:47 Read   358

EU Marketing Authorization offers the potential for broader access to ONCASPAR as Baxalta continues to build its innovative and diverse portfolio of differentiated oncology treatments

FDA permits marketing of fecal continence restoration system

MarketFDA2015-12-19 21:46 Read   275

The U.S. Food and Drug Administration today approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.

FDA allows marketing of cooling cap to reduce hair loss during chemotherapy

MarketFDA2015-12-09 10:42 Read   364

Today, the U.S. Food and Drug Administration cleared for marketing in the United States the first cooling cap to reduce hair loss (alopecia) in female breast cancer patients undergoing chemotherapy.

Impax Receives European Commission Marketing Authorization for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's Disease

MarketImpax2015-11-26 10:34 Read   568

Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease.

European Commission Approves Amgen's BLINCYTO® (blinatumomab) for the Treatment of Adults with Philadelphia Chromosome-Negative Relapsed or Refractory B-precursor Acute Lymphoblastic Leukemia

MarketAmgen2015-11-25 16:05 Read   424

Amgen today announced that the European Commission (EC) has granted conditional marketing authorization for BLINCYTO® (blinatumomab) for the treatment of adults with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL).

European Commission Grants Marketing Authorization for Gilead’s Single Tablet Regimen Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide) for the Treatment of HIV-1 Infection

MarketGilead2015-11-24 17:14 Read   1673

Gilead’s First TAF-based Single Tablet Regimen Demonstrates High Efficacy with Improved Renal and Bone Parameters Compared to TDF-based Regimens

Vertex Receives EU Approval for ORKAMBI® (lumacaftor/ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Two Copies of the F508del Mutation

MarketVertex2015-11-20 17:12 Read   472

ertex Pharmaceuticals Incorporated today announced that the European Commission has granted Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation.

Bayer Receives EU Approval for EYLEA® for the Treatment of Visual Impairment Secondary to Myopic Choroidal Neovascularization

MarketBayer2015-11-01 13:43 Read   635

Bayer has received approval from the European Commission for the eye drug EYLEA(aflibercept solution for injection into the eye) in a fifth indication.

FDA approves new therapy for certain types of advanced soft tissue sarcoma

MarketFDA2015-10-24 16:13 Read   543

The U.S. Food and Drug Administration today approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic).

Basilea announces that European Commission approves isavuconazole (CRESEMBA®) as a treatment for invasive aspergillosis and mucormycosis in the European Union

MarketPharmacodia.com2015-10-18 00:00 Read   284

October 16, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the European Commission has approved the antifungal isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.