FDA News

Brexpiprazole, an atypical antipsychotic, is the first and only medication approved to treat AD-associated agitation, reported in almost half of people with the disease.

Opill, a progestin-only oral contraceptive, if approved by the FDA, would be the first an only form of birth control in the US available without a physician's prescription.

The novel vaccine, from biopharma company GSK, is approved to prevent RSV-associated lower respiratory tract disease in adults aged ≥60 years.

Vowst is the first and only FDA-approved orally administered microbiota-based therapeutic for the prevention of recurrent C. diff infection in adults.

The wearable tubeless insulin delivery device provides a fixed rate of continuous long-acting insulin for 72 hours, requiring no needles or injections.

The oral calcitonin gene-related peptide receptor antagonist is now indicated for prevention in both episodic and chronic migraine.

The FDA action ends the use of monovalent COVID-19 mRNA vaccines from Pfizer/BioNTech and Moderna in favor of bivalent formulations to simplify the vaccination schedule, said the Agency.

Although the number of dispensed opioid prescriptions has somewhat declined, overdose deaths involving opioids continue to rise. The FDA is requiring stronger warnings of risk.

To be marketed as Rizafilm, the product is a disintegrating film formulation of the 5-HT-1 receptor antagonist and proven bioequivalent to Merck's Maxalt-MLT.

Ensitrelvir fast track status is supported by phase 3 study findings showing resolution of COVID-19 symptoms a full day earlier in those taking the drug vs placebo.