First oral antiviral approved for COVID-19; First topical treatment approved for epidermolysis bullosa; Xacduro gets green like for bacterial pneumonia; New 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 favour of 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.

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 the 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 votse on potential treatment for agitation with Alzheimer dementia; DEA deschedule drug; Migraine treatment indication expanded; A new device is cleared to aid in restless legs syndrome.

Implantable device approved for those with knee osteoarthritis; Prescribing Information labeling updated for opioids; Imbruvica indications withdrawn; Patch to combat excessive underarm sweating given green light; Novel treatment Fast Tracked for Type A and B influenza.

Treatment granted Emergency Use Authorization for hospitalized COVID-19 patients; Preterm-birth prevention treatment withdrawn from market; Sleep device for infants gets green light for marketing; New Padcev plus Keytruda indication; Mail-back system for unused opioids; Opioid overdose prevention device approved

Two diabetes drugs permanently discontinued; Consistent reduction in schizophrenia symptoms with an investigational Tx; Positive results for investigational Social Anxiety Disorder therapy; High-concentration Humira biosimilar approved; Sleep apnea treatment expanded for pediatrics with Down syndrome

COVID-19 Booster dose authorized for those aged 6 months through 4 years; Rapid STI point-of-care test for women is cleared; Rett syndrome and migraine Tx Approved; and The Oncology Drugs Advisory Committee takes a vote on a drug combination treatment for diffuse large b-cell lymphoma.