FDA approved sapropterin on December 13, 2007, to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due ro BH4-responsive phenylketonuria (PKU).
Pfizer Stops GLP-1 Obesity Trial Because of High Discontinuation Rates
Twice-daily danuglipron was being studied in a phase 2 study in adults with obesity. Pfizer is now conducting a pharmacokinetic study for a once-daily formulation.
FDA Sets Review Date for Zoryve in Atopic Dermatitis
The FDA has set a date of July 07, 2024, for Zorvye 0.15% for adults and children six and up with the chronic skin disease atopic dermatitis.
FDA Issues Complete Response for Novel Dry Eye Therapy
Regulators indicated that an additional trial would be needed to assess the efficacy of reproxalap to treat patients with dry eye. Aldeyra has submitted to the FDA a Special Protocol Assessment for the new trial.
FDA Sets Review for Nasal Opioid Rescue Drug
The product, OX124, uses a powder-based technology that provides rapid absorption of naloxone for patients experiencing an opioid overdose. The FDA review date is July 15, 2024.
FDA Approves First Treatment for Rare Noncancerous Tumors
Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.
FDA Sets Review Date for Therapy for Rare Connective Tissue Disorder
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 25, 2024, for prademagene zamikeracel to treat patients with recessive dystrophic epidermolysis bullosa.
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