- Drug Coverage
- Hypertrophic Cardiomyopathy (HCM)
- Vaccines: 2023 Year in Review
- Eyecare
- Urothelial Carcinoma
- Women's Health
- Hemophilia
- Heart Failure
- Vaccines
- Neonatal Care
- NSCLC
- Type II Inflammation
- Substance Use Disorder
- Gene Therapy
- Lung Cancer
- Spinal Muscular Atrophy
- HIV
- Post-Acute Care
- Liver Disease
- Pulmonary Arterial Hypertension
- Safety & Recalls
- Biologics
- Asthma
- Atrial Fibrillation
- Type I Diabetes
- RSV
- COVID-19
- Cardiovascular Diseases
- Breast Cancer
- Prescription Digital Therapeutics
- Reproductive Health
- The Improving Patient Access Podcast
- Blood Cancer
- Ulcerative Colitis
- Respiratory Conditions
- Multiple Sclerosis
- Digital Health
- Population Health
- Sleep Disorders
- Biosimilars
- Plaque Psoriasis
- Leukemia and Lymphoma
- Oncology
- Pediatrics
- Urology
- Obstetrics-Gynecology & Women's Health
- Opioids
- Solid Tumors
- Autoimmune Diseases
- Dermatology
- Diabetes
- Mental Health
FDA actions in brief
FDA approved prednisolone orally disintegrating tablets (Orapred ODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.
FDA approved prednisolone orally disintegrating tablets (OrapredODT, BioMarin/Alliant) for acute exacerbations of asthma as well as for persistent, severe asthma and for inflammation associated with certain conditions. It is the first orally disintegrating tablet formulation of prednisolone available in the United States.
Ezetimibe (Zetia, Merck/Schering-Plough) was approved in combination with fenofibrate for the treatment of hyperlipidemia. Previously, the drug was approved as monotherapy or in combination with statins for patients with hyperlipidema whose response to diet and exercise alone was inadequate.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
Read More
FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Read More
