December 1st 2023
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.
November 29th 2023
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.
November 28th 2023
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.
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.
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.
Bouquets and Brickbats for FDA OK of Alzheimer's Drug Aduhelm
The Alzheimer's Association praises the approval but not the price tag. A Harvard Medical School professor who resigned from an FDA advisory committee says the OK "was probably the worst approval decision in recent U.S. history" in his resignation letter.
FDA Greenlights Controversial Aducanumab, Biogen's Alzheimer’s Treatment
Today's approval goes against the advice of an outside advisory committee.
FDA clears first chronic weight loss drug in 7 years
Semaglutide injection is a weekly injection for chronic weight management in adults.
FDA OKs first targeted therapy for lung cancer with certain type of EGFR mutations
About 2% to 3% of patients with nonsmall cell lung cancer have EGFR exon 20 insertion mutations targeted by newly approved Rybrevant.
FDA OKs first-of-its-kind treatment for paroxysmal nocturnal hemoglobinuria
OptumRx had identified pegcetacoplan as one of the top 5 drugs in the pipeline this year.
Blockbuster Farxiga Gets New Chronic Kidney Disease Indication
The AstraZeneca drug is the first SGLT2 inhibitor approved for chronic kidney disease regardless of whether the patient has diabetes.
2 Clarke Drive Cranbury, NJ 08512