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.
FDA Approves Upadacitinib for Severely Active RA
Humira successor indicated for adults with inadequate response or intolerance to methotrexate.
FDA Approves Fedratinib (Inrebic) for Myelofibrosis
First new drug approval for the condition in nearly a decade.
FDA Approves Turalio (Pexidartinib) for TGCT
Kinase inhibitor oral capsules.
New Warnings for Tofacitinib Issued by FDA
Black box warns of increased risk of blood clots and death.
FDA Approves Hadlima (Adalimumab-bwwd) Biosimilar
TNF blocker biosimilar to Humira (adalimumab, Abbvie).
FDA Approves Ruxience, a Rituxan Biosimilar
CD20-directed antibody indicated for several cancers and other conditions.
First Generic Lyrica Capsules Approved by FDA
Distributed by Invagen, a subsidiary of Cipla Ltd.
FDA Approves Otezla (Apremilast) to Treat Oral Ulcers
Fourth indication for the drug since 2014.
FDA Approves Recarbrio for UTI and Intra-Abdominal Infections
Combination drug indicated for infections caused by susceptible gram-negative bacteria.
New Drug Review: Erdafitinib
First oral drug for advanced or metastatic bladder cancer.
Gadavist (Gadobutrol) Approved as First Cardiac MRI Contrast Agent
Fourth approval for use in assessing myocardial perfusion and late gadolinium enhancement.
Opicapone (Ogentys) for Parkinson’s Disease
COMT inhibitor to be used as an adjunctive treatment to levodopa/carbidopa.
