Biotech Stocks Facing FDA Decision In August 2023

(RTTNews) - As July draws to a close, let's take a look at the some of the regulatory news stories that made headlines in the month. Additionally, we'll delve into the promising prospects related to FDA approval that lie on the horizon.

Drug overdose is a significant public health concern in the United States. On July 28, the FDA approved RiVive, developed by Harm Reduction Therapeutics, for the emergency treatment of known or suspected opioid overdose. This marks the second over-the-counter naloxone nasal spray product to receive regulatory approval in the U.S. The first one, Emergent BioSolutions' NARCAN nasal spray, obtained approval in March of this year.

A new drug by the name Beyfortus, developed by AstraZeneca, for the prevention of respiratory syncytial virus lower respiratory tract disease in babies and toddlers, was approved by the FDA on July 17. According to the American Academy of Pediatrics, around 1% to 3% of children below 12 months old in the United States require hospitalization annually due to RSV (Respiratory Syncytial Virus).

On July 13, the FDA approved Perrigo's Opill, the first nonprescription daily oral contraceptive. The approval of this progestin-only oral contraceptive pill offers consumers the choice to buy oral contraceptive medication without a prescription from various retail outlets, including drug stores, convenience stores, grocery stores, and online platforms.

Let's take a look at the biotech stocks awaiting FDA decision in August.