Biotech Stocks Facing FDA Decision In June 2023

(RTTNews) - As we step into the third month of the second quarter, let's take a quick look at the regulatory news that made headlines in May and offer you a sneak peek into the anticipated FDA decisions coming up in June.

On May 1, the FDA conditionally approved Elanco's Varenzin-CA1, the first drug for anemia in cats with chronic kidney disease.

Arexvy, the first respiratory syncytial virus (RSV) vaccine, received regulatory approval in the U.S., for use in individuals 60 years of age and older, on May 3.

Otsuka Pharma's Rexulti was approved by the FDA for the expanded use in treating agitation associated with dementia due to Alzheimer's disease on May 11. This marks the first FDA-approved treatment option for this indication.

Astellas Pharma's Veozah was granted FDA approval on May 12, for the treatment of moderate to severe hot flashes caused by menopause.

Krystal Biotech's Vyjuvek received FDA approval on May 19, becoming the first topical gene therapy for treatment of wounds in patients with Dystrophic Epidermolysis Bullosa.

On May 22, the FDA approved Opiant Pharma's Opvee, a prescription nasal spray to reverse opioid overdose.

Pfizer's Paxlovid was approved by the FDA on May 26, becoming the first oral antiviral to receive regulatory nod in the U.S. for the treatment of COVID-19 in adults.

Now, let's take a look at the biotech stocks awaiting FDA decision in June.