First oral antiviral approved for COVID-19; First topical treatment approved for epidermolysis bullosa; Xacduro gets green like for bacterial pneumonia; Nasal spray for opioid overdoses; Child cough suppressant recalled.
FDA requires label updates for the entire class of prescription stimulants; Novel treatment approved for menopause symptoms; FDA Committee takes votes on potentially accelerated approval of Duchenne muscular dystrophy gene therapy; Fungal meningitis outbreak in US; Wearable child thermometer recalled.
Panel votes unanimously in favor of an over-the-counter change for contraceptive pill; First pharmacological therapy for agitation associated with dementia due to Alzheimer disease; Elfabrio approved for the treatment of Fabry disease; Farxiga approval expanded; Bacterial contamination concerns for certain COVID-19 at-home tests.
The table below is a review of notable updates that occurred in April 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.
Investigational treatment for early Alzheimer disease shows promise; First vaccine for the prevention of lower respiratory tract disease caused by RSV; Nightly granules approved for narcolepsy; Latest health tech advance in toilets; And FDA warns of energy boosting over-the-counter inhalants.
Large recall of drugs due to company shutdown; First orally administered fecal microbiota treatment given green light; Treatment approved for certain ALS patients; Type 2 diabetes insulin delivery system; FDA issue safety alert concerning eyedrops.
Updates to COVID-19 vaccines; FDA panel votes on potential treatment for agitation with Alzheimer dementia; DEA deschedules drug; Migraine treatment indication expanded; A new device is cleared to aid in restless legs syndrome.
Implantable device approved to for knee osteoarthritis; Prescribing Information labelling updated for opioids; Imbruvica has indications withdrawn; Patch to combat excessive underarm sweating given green light; Novel treatment Fast Tracked for Type A and B influenza.
