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.

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.

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.

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.…

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

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 …

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 pyelonephriti…

First treatment approved to reduce allergic reactions in those with multiple food allergies; T-cell therapy given accelerated approval to treat unresectable or metastatic melanoma; Vit D supplement recalled due to superpotency; cannabidiol may help resolve the symptoms of pericarditis; FDA warn against certain wearables that claim to measure blood …

FDA approves first treatment for severe frostbite; Eohilia gains approval to treat eosinophilic esophagitis; MDMA accepted for Priority Review for PTSD; novel subcutaneous to be reviewed for prurigo nodularis, atopic dermatitis; OTC pulse oximeter device is cleared.

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.

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

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

Gene therapy approved for beta thalassemia; treatment for preventing of chronic inflammatory demyelinating polyneuropathy relapse; device to aid dermatologist referrals; vertebral strength device for low-bone mass; Narcan shelf-life extension

Researchers examine link between diabetes, obesity treatments and suicidal ideation; topical treatment for molluscum contagiosum; IV bags recalled following discovery that they may contain twice as much of the labeled drug; update on the penicillin shortage; newly cleared test measures HbA1c from menstrual blood.…

An expert panel rank the 30 best diets for 2024; Counterfeit Ozempic on the rise; Myasthenia gravis drug approved; Herpes tests may produce false positives; Safety concerns over IV promethazine hydrochloride.

Topical gel approved to treat partial thickness wounds in epidermolysis bullosa; Priority Review given to 21-valent pneumococcal conjugate vaccine; sensory and motor stimuli video game for ADHD gains expanded age approval; on-demand HIV prevention for women; multiple food allergy drug

The ADA release their new guidance for the management of diabetes 2024; a new blood collection device obtains lab-quality samples using a the finger; novel treatment for postpartum depression becomes available; a study for a male birth control pill begins; and a Public Benefit Corporation seeks approval for an MDMA-assisted therapy.…

Novel weight loss treatment now available in pharmacies; Novo Nordisk warns about the risks of compounded semaglutide; treatment approved for paroxysmal nocturnal hemoglobinuria; over-the-counter insemination kit cleared by the FDA.

Safety alert issued for serious reactions to certain seizure drugs; Drug approved to treat a rare form of tumor; T-cell malignancies reported with cell immunotherapies; organ transplant rejection treatment recalled; CPAP machine associated with reports of burns and fires.

First chikungunya vaccine approved; FDA send warning letter to Amazon about ophthalmic products; at-home STD test cleared; Bayer withdraw lymphoma drug; and a combo treatment to reduce catheter-related bloodstream infections is approved.

New weight management approved; Novo Nordisk discontinue Levemir; adjunctive system for hypertension patients; frontotemporal dementia treatment given Fast Track designation; and the FDA advise against use of glucose supplement.

FDA urge immediate discontinuation for eye drop products; safety alert issued for the pediatric Moderna COVID-19 vaccine; novel heartburn medicine approved; Stelara biosimilar approved; and an antibody to prevent fentanyl overdose gets fast tracked.

New pentavalent meningococcal vaccine approved; Gohibic’s shelf-life extended by 6 months; maintenance treatment approved for adults with moderately to severely active ulcerative colitis or Crohn disease; self-administered option for FluMist Quadrivalent accepted for review; intravenous combo formulation of acetaminophen and ibuprofen approved for …

FDA approves a novel treatment for major depressive disorder; vote taken on stem cell therapy for ALS; preservation-free Iyuzeh now available; CDC recommends RSV vaccine for during pregnancy; investigational treatment shows promise in familial chylomicronemia syndrome.

Bacterial pneumonia treatment now available; FDA deny proposed anaphylaxis treatment; Results on flu vaccine efficacy; More flexible dosing for Talicia; Change in the therapeutic equivalence for organ rejection drug generic.

The FDA and CDC greenlight updated COVID-19; prescription drug for dry eye disease now available; head-to-head study comparing Skyrizi to Stelara for Crohn disease; the REMS program has been updated for IBS treatment Lotronex; and the FDA cracks down on companies selling unnaproved eye products.

With fall on the horizon, MPR sat down with Assistant Professor of Clinical Pharmacy at the University of California San Diego, Dr. Abdul-Mutakabbir. Our wide ranging talk covers the updated COVID-19, flu and RSV vaccines. We also discuss vaccine hesitancy, health equity and representation in medicine.…

New vaccine guidelines issued for the 2023-2024 flu season; USPSTF make recommendations on PrEP prescribing; maternal RSV vaccine; updated COVID vaccine shows strong immune response; new treatment approved for rare immune disease.

FDA issue recommendations to avoid Company's tests; RSV vaccine now available for older adults; New treatments approved for fibrodysplasia ossificans progressiva and for those with metastatic uveal melanoma with unresectable hepatic metastases; and gastrointestinal associations issue a statement regarding GLP-1 use prior to upper gastrointestinal e…

Oral postpartum depression treatment approved; generic naloxone nasal spray now available; weight management drug shows promise in reducing major cardiovascular events; CDC recommends routine use of RSV vaccine; social anxiety disorder spray shows potential.

Drug agencies issue letter addressing the prescription stimulant shortage; electronic transfer of controlled substances given green light; oral contraceptives recalled; expanded indication for Ebola vaccine; and a new over-the-counter opioid overdose treatment.

Single-use application to treat the molluscum contagiosum approved; Xdermvy has gotten the green light to treat demodex blepharitis; warfarin reversal treatment for use in urgent surgery; weight loss drug in short supply through 2023; cervical pessary assessed for reducing preterm birth.

Study supports the benefit of potential new Alzheimer drug; RSV treatment approved for neonates and infants; Veklury approval expanded; a blood test used to diagnose life-threatening heart muscle injuries has been recalled; Brenzavvy available for adults.

First over-the-counter birth control pill; expanded approval for Leqvio; Gavreto has an indication withdrawn; batches of Albuterol inhalers recalled; results from analysis of paclitaxel-coated devices.

New approvals for alopecia, generalized myasthenia gravis and type 1 diabetes; New colonoscopy prep option; And FDA denies application for pre-chirrotic fibrosis due to NASH.

FDA revoke Emergency Use Authorization for a COVID-19 vaccine; New approval for treatment of iron deficiency in patients with heart failure; Lumryz now available for excessive daytime sleepiness; Vowst approved for C. difficile infection; Prevymis approved for prophylaxis of CMV disease in adult kidney transplant recipients.…

New vaccine for lower respiratory tract disease; A new treatment for heart failure; Concerns over some compounded semaglutide; New opioid use disorder treatment; Motion sickness Tx shows promise.

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.

Limits on acetaminophen levels in combination opioid products linked to declines in liver injuries; Investigational Alzheimer disease drug fails to show efficacy; Bempedoic acid assessed for reducing major adverse cardiovascular events; Commercial blood test for suspected TBIs; Mammography regulations updated.…

Kevzara approved for polymyalgia rheumatica; Skyclarys approved for Friedreich ataxia; Emergency authorization granted to at-home COVID-19, flu test; Drug-resistant bacteria virus spiking in the US; FDA clamps down on unlawful xylazine imports.

Results from postexposure prophylaxis study of molnupiravir; Treatment approved to reduce proteinuria in adults with primary immunoglobulin A nephropathy; Intravitreal injection approved for geographic atrophy secondary to AMD; Potential vaccines for melanoma and pregnant individuals to help protect from RSV complications in infants.…