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FDA approves Darzalex for patients with previously treated multiple myeloma

BLA ApprovalFDA2015-11-17 10:41 Read   367

FDA granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma.

FDA approves modified antihemophilic factor for hemophilia A

BLA ApprovalFDA2015-11-16 12:26 Read   628

The U.S. Food and Drug Administration today approved Adynovate, Antihemophilic Factor (Recombinant), PEGylated for use in adults and adolescents, aged 12 years and older, who have Hemophilia A.

GlaxoSmithKline bags an FDA OK for its asthma drug with eyes on a respiratory turnaround

BLA Approvalstatement2015-11-05 15:16 Read   357

GlaxoSmithKline won FDA approval for an antibody designed to treat severe asthma.

FDA approves new Novartis dual combination bronchodilator Utibron™ Neohaler® for patients with chronic obstructive pulmonary disease

BLA ApprovalPipelinereview2015-11-02 18:31 Read   580

October 29, 2015 I Novartis announced today that FDA has approved the dual combination bronchodilator Utibron™ Neohaler (indacaterol/glycopyrrolate) inhalation powder for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD)

FDA approves Yervoy to reduce the risk of melanoma returning after surgery

BLA ApprovalFDA2015-10-29 18:26 Read   246

Today FDA expanded the approved use of Yervoy (ipilimumab) to include a new use as adjuvant therapy for patients with stage III melanoma, to lower the risk that the melanoma will return following surgery.

FDA approves first-of-its-kind product for the treatment of melanoma

BLA ApprovalFDA2015-10-28 17:06 Read   1173

The U.S. Food and Drug Administration today approved Imlygic (talimogene laherparepvec), the first FDA-approved oncolytic virus therapy, for the treatment of melanoma lesions in the skin and lymph nodes.

FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder

BLA ApprovalFDA2015-10-22 15:37 Read   457

The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.

FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa

BLA ApprovalPharmacodia.com2015-10-17 00:00 Read   959

The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

FDA Approves Octapharma's NUWIQ for the Treatment of Adults and Children with Hemophilia A

BLA ApprovalPharmacodia.com2015-09-14 00:00 Read   929

Octapharma USA announced the U.S. FDA has approved NUWIQ?, Antihemophilic Factor (Recombinant), an intravenous therapy for adults and children living with Hemophilia A. The NUWIQ? approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and perioperative management of bleeding.

U.S.FDA approved Praluent (Alirocumab) to treat certain patients with high cholesterol

BLA ApprovalPharmacodia.com2015-07-24 00:00 Read   280

On July 24, 2015， FDA approved Praluent (Alirocumab), the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.The drug was codeveloped by Sanofi-Aventis and Regeneron. And it is approved for use in addition to diet and maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH) or patients with clinical atherosclerotic cardiovascular disease such as heart attacks or strokes, who require additional lowering of LDL cholesterol.

EMA approved Repatha (Evolocumab) to treat uncontrolled cholesterol

BLA ApprovalPharmacodia.com2015-07-21 00:00 Read   452

On July 21, 2015, the European Commission (EC) had granted marketing authorization for Repatha (evolocumab),the first proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontrolled cholesterol who require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction.The drug was developed by Amgen.