New Multiple Sclerosis Treatment Approved by FDA
Delayed-release oral capsules for various forms of the disease.
Baxdela Now Approved for Bacterial Pneumonia
Commercial launch suspended due to manufacturer liquidity.
FDA Approves Biophen for Hypotension in Anesthesia Settings
New formulation improves safety for patients.
FDA Approves Mealtime Insulin for Use with Infusion Pumps
Previously approved for IV infusion.
Ustekinumab Gains FDA Approval as Ulcerative Colitis Treatment
Fourth indication expansion for the 2009 drug.
Dapagliflozin Approved to Reduce Hospitalization in Diabetes Patients
Reduces risk for heart failure and cardiovascular disease hospitalizations.
FDA Approves Triple Combination Therapy for Cystic Fibrosis
Drug able to treat 18,000 people will cost over $300k per year.
Minocycline Topical Foam 4% Approved by FDA for Acne Vulgaris
Available for prescribing starting January 2020
FDA Approves Baloxavir Marboxil for High-Risk Flu Patients
First approved in 2018 for patients 12 years of age and older.
Cetirizine IV Approved for Pediatric Acute Urticaria
Originally approved in 1995 for use in adults only.
FDA Approves Asenapine for Schizophrenia
Administered via a once-daily transdermal patch.
Dexcom G6 Continuous Glucose Monitor Approved by FDA
New CGM eliminates fingersticks, introduces new data presentation.
Rare Light Sensitivity Disorder Drug Approved by FDA
Afamelanotide released through subcutaneous implant.
Wilate Approved for Hemophilia A Treatment
Also indciated to control bleeding and perioperative management.
Brolucizumab-dbll Approved by FDA for Wet AMD
Injection for leading cause of severe vision loss and legal blindness.
FDA Approves Trifarotene Cream for Acne Treatment
First new treatment of its kind in over 20 years.
Rituximab Gains First Pediatric Approval
For granulomatosis with microscopic polyangiitis in children.
FDA Approves Canagliflozin Indication Expansion
Now approved for risk reductions in patients with type 2 diabetes mellitus.
FDA Approves Jynneos for Smallpox and Monkeypox in Adults
Will be part of the U.S.’s public health emergency medical supplies and pharmaceuticals.
Investigational Guillain-Barré Syndrome Treatment Granted FDA Fast Track Designation
Monoclonal antibody for autoimmune and neurodegenerative disorders.
New Semaglutide Dosage Forms Approved by FDA
Now approved in 7mg and 14 mg tablets.
Potential Treatment for Traumatic Brain Injury Receives Regenerative Advanced Therapy Designation
Derived from cultured adult bone marrow-derived mesenchymal stem cells that have undergone temporary genetic modification.
Obinutuzumab Receives Breakthrough Therapy Designation from FDA
Monoclonal antibody shows potential for lupus nephritis treatment.
FDA Approves First Drug Under Project Orbis
Combination therapy for advance endometrial carcinoma.
Tenapanor Approved for Adults with IBS-C
NHE3 inhibitor administered as 50 mg oral tablets.
FDA Grants Tepotinib Breakthrough Therapy Designation
Investigational oral MET kinase inhibitor from Merck.
FDA Approves New Generic for Rare HT-1 Disorder
Oral supplements for metabolic disorder.
Decitabine and Fosaprepitant Generics Approved by FDA
First generic specialty injections approved for Novadoz Pharmaceuticals.
New Drug Review: Vraylar for Bipolar I Disorder
Cariprazine demonstrated greater improvement on the MADRS.
FDA Approves Lefamulin for Community-Acquired Bacterial Pneumonia
New pleuromutilin antibiotic IV and oral tablets.
