FDA Approvals News
Latest fda approvals news, reviewed by pharmacists.
FDA Approvals articles
FDA ApprovalsHemophilia A Treatment Gets Green Light
Kovaltry antihemophilic factor (recombinant) approved to treat hemophilia A
FDA ApprovalsA New Formulation for Melphalan
Evomela (melphalan) approved to treat multiple myeloma
FDA ApprovalsA New Job for Xalkori
Pfizer's Xalkori (crizotinib) approved to treat advanced non-small cell lung cancer with tumors that have ROS-1 gene alteration
FDA ApprovalsSmallest Single-Tablet HIV Rx Approved
Odefsey (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg) approved to treat HIV
FDA ApprovalsAnother Hemophilia Treatment Option
Idelvion, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, approved for use in children, adults with hemophilia B
FDA ApprovalsFDA Expands Indication For Breast Cancer Rx
Palbociclib now approved to treat HR-positive, HER2-negative breast cancer in women following endocrine therapy
FDA ApprovalsNew Epilepsy Rx Gets FDA Nod
Briviact approved to treat partial onset seizures in patients age 16 years and older with epilepsy
FDA ApprovalsFDA Approves New Liposarcoma Rx
Halaven approved for the treatment of liposarcoma by FDA
FDA ApprovalsA New Type of ADHD Rx
Adzenys XR-ODT is only FDA-approved extended-release, orally disintegrating tablet for ADHD
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FDA ApprovalsNew ADHD Rx Gets FDA Nod
Adzenys XR-ODT approved by FDA for attention-deficit/hyperactivity disorder in patients age 6 and older
FDA ApprovalsApproved: Diabetic Foot Ulcer Treatment
Integra Omnigraft Dermal Regeneration Matrix FDA-approved to treat diabetic foot ulcers
FDA ApprovalsOmnigraft Gains Approval
Integra Omnigraft Dermal Regeneration Matrix approved to treat diabetic foot ulcers
FDA ApprovalsA New Treatment for Gout
Zurampic (lesinurad) approved to treat hyperuricemia tied to gout
FDA ApprovalsLung Disease Rx Gets Green Light
Uptravi (selexipag) tablets approved to treat adults with pulmonary arterial hypertension
FDA ApprovalsFDA Expands Pembrolizumab Label
Pembrolizumab (brand name Keytruda Injection) approval expanded to include initial treatment of patients with unresectable or metastatic melanoma
FDA ApprovalsFecal Continence Restoration System Approved
Fenix Continence Restoration System approved to treat fecal incontinence
FDA ApprovalsNew Wearable Defibrillator for Kids
LifeVest wearable cardioverter defibrillator approved for kids at risk of sudden cardiac arrest
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FDA ApprovalsBasaglar Gets FDA Green Light
Basaglar (insulin glargine injection), from Eli Lilly, approved to treat diabetes
FDA ApprovalsAn Rx to Reverse Muscle Relaxants During Surgery
Bridion (sugammadex) injection FDA-approved to reverse neuromuscular blockade induced by rocuronium bromide, vecuronium bromide
FDA ApprovalsRx to Reverse Neuromuscular Blocking Approved
Bridion (sugammadex) injection approved to reverse effects of neuromuscular blockade induced by rocuronium bromide, vecuronium bromide
FDA ApprovalsA New Option for ALK-Positive Lung Cancer
Alecensa (alectinib) approved to treat advanced ALK-positive non-small cell lung cancer
FDA ApprovalsChemo Overdose Rx Approved
Vistogard (uridine triacetate) approved to treat fluorouracil, capecitabine overdose
FDA ApprovalsPediatric Ear Rx Gets FDA Nod
Otiprio (ciprofloxacin otic suspension) approved to treat pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement
FDA ApprovalsApproved: Possible Solution to Chemotherapy Hair Loss
Dignitana DigniCap Cooling System, to reduce hair loss in breast cancer patients, cleared for marketing by FDA