FDA Approvals News
Latest fda approvals news, reviewed by pharmacists.
FDA Approvals articles
FDA ApprovalsCombo HIV Tablet Approved
Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide) approved to treat HIV
FDA ApprovalsA New Option for Severe Asthma
Nucala (mepolizumab), from GlaxoSmithKline, approved to treat severe asthma
FDA ApprovalsOK for New Asthma Rx
Nucala (mepolizumab), from GlaxoSmithKline, approved for severe asthma treatment
FDA ApprovalsFirst-Time Generics Approved in October
Generic drugs approved by US Food and Drug Administration in October 2015
FDA ApprovalsCombo COPD Rx Coming Soon
Utibron Neohaler (indacaterol/glycopyrrolate), from Novartis, approved to treat COPD
FDA ApprovalsNew COPD Rx Lands FDA Approval
Novartis dual combination bronchodilator Utibron Neohaler approved for chronic obstructive pulmonary disease patients
FDA ApprovalsYervoy Gets a New Use
Yervoy (ipilimumab), from Bristol-Myers Squibb, approved to reduce risk of melanoma returning after surgery
FDA ApprovalsNovel Melanoma Lesion Rx Is a Go
Imlygic (talimogene laherparepvec), an oncolytic virus therapy from Amgen's BioVex, approved to treat melanoma lesions
FDA ApprovalsNew Option for Chronic Pain Management
Belbuca (buprenorphine) buccal film approved for use in patients with severe, chronic pain
FDA ApprovalsFirst Rx for Rare Disease Gets FDA OK
Strensiq (asfotase alfa) approved to treat perinatal, infantile and juvenile-onset hypophosphatasia by FDA
FDA ApprovalsSoft Tissue Sarcoma Rx Approved
Yondelis (trabectedin) approved to treat liposarcoma and leiomyosarcoma by FDA
FDA ApprovalsA New Rx for Advanced Pancreatic Cancer
Onivyde (irinotecan liposome injection) approved to treat advanced pancreatic cancer by FDA
FDA ApprovalsFDA OKs Hyperkalemia Rx
Veltassa (patiromer for oral suspension) approved to treat hyperkalemia by FDA
FDA ApprovalsGreen Light for Kid-Friendly ADHD Rx
Dyanavel XR (once-daily liquid amphetamine), from Tris Pharma, approved to treat ADHD
FDA ApprovalsHereditary Bleeding Disorder Rx Approved
Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency, approved by FDA
FDA ApprovalsPradaxa Reversal Rx Approved
Praxbind (idarucizumab), from Boehringer Ingelheim, approved to reverse effects of Pradaxa (dabigatran)
FDA ApprovalsFDA Expands Opdivo Approval
Opdivo (nivolumab) approved to treat advanced, non-squamous, non-small cell lung cancer
FDA ApprovalsPulmonary Arterial Hypertension Rx Combo Approved
Letairis (ambrisentan) in combination with tadalafil (Adcirca) approved to treat pulmonary arterial hypertension by FDA
FDA ApprovalsA Shot for Schizophrenia
Aristada (aripiprazole lauroxil) extended-release injection to treat schizophrenia approved by FDA
FDA ApprovalsMelanoma Rx May Treat Lung Cancer, Too
Keytruda (pembrolizumab), from Merck, FDA-approved to treat non-small cell lung cancer
FDA ApprovalsAdvanced Non-Small Cell Lung Cancer Rx Approved
Keytruda (pembrolizumab) approved to treat advanced non-small cell lung cancer by FDA
FDA ApprovalsFDA OKs Combo Skin Cancer Rx
Nivolumab (Opdivo) combined with ipilimumab (Yervoy) approved to treat advanced melanoma
FDA ApprovalsAdvanced Colorectal Cancer Rx Approved
Lonsurf (trifluridine, tipiracil) approved to treat advanced colorectal cancer by FDA
FDA ApprovalsSchizophrenia, Bipolar Disorder Rx Approved
Vraylar (cariprazine) approved to treat schizophrenia, bipolar disorder