- 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 Pipeline preview, April 2008
Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.
Recommended for approval
• Rotavirus vaccine, live, oral (Rotarix, GlaxoSmithKline) to prevent rotavirus gastroenteritis in infants
Nonapprovable designations
• Olanzapine long-acting injection (Zyprexa, Eli Lilly) for the treatment and maintenance therapy of schizophrenia in adult patients
Fast-track designations
• Mycobacterial cell wall-DNA complex (Urocidin, Bioniche Life Sciences) for the first-line treatment of non-muscle-invasive bladder cancer
• Talactoferrin (Agennix) as monotherapy for the treatment of patients with non-small cell lung cancer (NSCLC) in whom ≥2 previous therapies have failed
• Levodopa/carbidopa intestinal gel (Duodopa, Solvay) for the long-term treatment of motor fluctuations associated with advanced PD
Priority review
• Prasugrel (Daiichi Sankyo/Eli Lilly) for the treatment of acute coronary syndrome (ACS) in patients undergoing percutaneous coronary intervention (PCI)
• Eltrombopag (Promacta, GlaxoSmithKline) for the short-term treatment of chronic idiopathic thrombocytopenic purpura (ITP)
• Difluprednate ophthalmic emulsion (Durezol, Sirion) for the treatment of postoperative ocular inflammation
• EUR-1008 (Zentase, Eurand) for the treatment of pancreatic insufficiency
Orphan drug designations
• ARG201 (arGentis) for the treatment of diffuse systemic sclerosis (systemic scleroderma)
• MGCD0103 (Pharmion/MethylGene) for the treatment of acute myelogenous leukemia (AML)
• Triphendiol (Marshall Edwards) for the treatment of stage IIB through stage IV malignant melanoma
• ADH-1 (Adherex Technologies) in combination with melphalan for the treatment of stage IIB/C, III, and IV malignant melanoma
• Levofloxacin solution for inhalation (Mpex) for the treatment of pulmonary infections caused by Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis
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
