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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.

FDA approves Zurampic to treat high blood uric acid levels associated with gout

NCE ApprovalFDA2015-12-23 14:24 Read   255

FDA today approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of uric acid in the body.

European Commission Approves Amgen's IMLYGIC™ (talimogene laherparepvec) As First Oncolytic Immunotherapy In Europe

BLAmgen2015-12-21 14:57 Read   543

Amgen today announced that the European Commission has approved the use of IMLYGIC™ (talimogene laherparepvec) for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a), with no bone, brain, lung or other visceral disease. IMLYGIC is the first oncolytic immunotherapy to demonstrate therapeutic benefit for patients with metastatic melanoma in a Phase 3 clinical trial.

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 approves wearable defibrillator for children at risk for sudden cardiac arrest

IndicationFDA2015-12-18 10:07 Read   398

The U.S. Food and Drug Administration today approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent.

FDA approves Basaglar, the first “follow-on” insulin glargine product to treat diabetes

BLA ApprovalFDA2015-12-17 13:25 Read   527

The U.S. Food and Drug Administration today approved Basaglar (insulin glargine injection), a long-acting human insulin analog to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. 

FDA approves Bridion to reverse effects of neuromuscular blocking drugs used during surgery

NCE ApprovalFDA2015-12-16 17:23 Read   445

The U.S. Food and Drug Administration today approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used during certain types of surgery in adults.

FDA approves first emergency treatment for overdose of certain types of chemotherapy

IndicationFDA2015-12-14 14:39 Read   423

FDA today approved Vistogard for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or capecitabine, or who develop certain severe or life-threatening toxicities within four days of receiving these cancer treatments.

FDA approves new oral therapy to treat ALK-positive lung cancer

IndicationFDA2015-12-12 21:59 Read   378

FDA today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung cancer (NSCLC) whose disease has worsened after, or who could not tolerate treatment with, another therapy called Xalkori (crizotinib).

FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients

BLFDA2015-12-09 11:12 Read   316

Today, the U.S. Food and Drug Administration approved Kanuma (sebelipase alfa) as the first treatment for patients with a rare disease known as lysosomal acid lipase (LAL) deficiency.

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.

FDA approves first recombinant von Willebrand factor to treat bleeding episodes

BLFDA2015-12-09 10:36 Read   313

FDA today approved Vonvendi, von Willebrand factor (Recombinant), for use in adults 18 years of age and older who have von Willebrand disease (VWD).