Asthma treatment gains approval for severe cases in pediatrics; Dovato gains expanded indication; Decision taken to remove ALS drug from market; Complete Response Letter issued for apomorphine device; At-home Mpox test kit made available ..read more

First prescription smartphone app approved for major depressive disorder; Novel blood test to detect TBI; Zevtera approved for bloodstream infections; Mpox vaccine is now commercially available; Algorithm cleared for LVEF dectection.   ..read more

Preexposure prophylaxis approved for COVID-19; Nexletol and Nexlizet gain expanded approval; Novel Duchenne muscular dystrophy treatment; First blood test to screen for malaria in donors; Warning letter for OTC topical analgesic products.   ..read more

Nasal spray approved for chronic rhinosinusitis; Endothelin receptor antagonist gains approval to lower blood pressure in hypertension; One-time stem cell treatment approved for metachromatic leukodystrophy; NASH treatment gains accelerated approval; New automated insulin delivery system for type 1 diabetes.   ..read more

Weight loss treatment has approval expanded; Paxlovid with Emergency Use Authorized label must be disposed of; psychedelic gets Breakthrough therapy designation; Advisory Committee announce meeting to discuss Alzheimer treatment; ALS treatment trial results ..read more

Over-the-counter birth control pill to be available in the coming weeks; first over-the-counter continuous glucose monitor to be available starting this summer; the 2024-2025 US influenza season vaccine will be trivalent; LSD granted Breakthrough Therapy for treatment of generalized anxiety disorder; interchangeable biosimilars to Prolia and Xgeva approved.  ..read more

FDA withdraw multiple myeloma treatment after a confirmatory trial showed an increased risk of death; latest efficacy results for lower respiratory tract disease vaccine; CDC Chikungunya virus vaccine recommendations; Complete Response Letter issued to investigative schizophrenia treatment; new treatment for complicated UTIs including pyelonephritis; over-the-counter eye ointments recalled.   ..read more

Combination intravenous formulation of acetaminophen and ibuprofen approved; recommendations from the ADA for dealing with acute dental pain; RSV vaccine under review for younger adult age group; Gilead call halt on investigational leukemia treatment hagrolimab; athlete foot spray recalled ..read more

Biogen discontinue Alzheimer treatment; The American Academy of Dermatology issue new acne vulgaris management guidelines; Update for ongoing availability of Paxlovid; Narcolepsy/ADHD treatment recalled for containing wrong drug; FDA warn against copycat eye drop products ..read more

T-cell malignancies prompt label changes for certain T-cell immunotherapies; Novel opioid provides in-built protection against overdose; Hypocalcemia risk with Prolia; At-Home semen insemination kit cleared; New asthma rescued medicine approved ..read more