MPR Weekly Dose

New indication for Kerendia; investigational therapy shows promise for hypertension; Novolog interchangeable biosimilar gets approval; trial results for hormone-free contraceptive; Shingrix now supplied in a prefilled syringe.

Lawsuit filed against RFK Jr over vaccine policy changes; oral on-demand treatment approved for HAE; OTC cuffless blood pressure monitor gets greenlit; dosing schedule update for Alzheimer treatment; REMS requirement removed for endothelin receptor antagonist meds.

Wristband that provides relief for upper limb tremor is approved; FDA warns of clinically significant weight loss in younger kids taking ADHD meds; REMS removed for CAR T-cell immunotherapies; treatment approved for lung cancer patients with EGFR exon20 insertion mutations; and CDC committee recommends removing preservative from flu vaccines.

Novo Nordisk end their partnership with Hims & Hers; update to Vizamyl labeling; autoinjector approved for pediatrics with lupus nephritis; psilocybin shows promise in treatment-resistant depression; sotatercept phase 3 trial results.

Nucala gains new indication; the FDA are set to require placebo-controlled trials to evaluate COVID-19 vaccines; pruritus reported following discontinuation of antihistamines; oral carbapenem antibiotic looks promising for cUTIs; investigational celiac disease Tx gets Fast Tracked

At-home cervical cancer screening device gains clearance; the FDA indicates it wants to remove pediatric fluoride products from the market; the chikungunya vaccine is put on-pause for some individuals; a subcutaneous autoinjector is approved to treat migraines; and the FDA will review a gene therapy for Hunter syndrome.

A new epinephrine nasal spray dosage has been approved for pediatrics; FDA agree to review Semaglutide for weight management; A wearable defibrillator is cleared to prevent sudden cardiac arrest; a low dose formulation of chlorthalidone is approved to treat hypertension; and Selarsdi is now interchangeable with Stelara.

Rinvoq approved for giant cell arteritis; telehealth companies collaborate with Novo Nordisk for Wegovy access; epidermolysis bullosa wound healing treatment approved; Imaavy approved for gMG; New nasal powder approved for migraine treatment.

The FDA issues alert regarding a compounded topical finasteride; plant-based alkaloid shows improvement for smoking cessations; potential new treatment option for GERD; and the CDC's Advisory Committee on Immunization Practices make new recommendations.

Pfizer ends danuglipron clinical program for obesity; FDA warns about counterfeit Ozempic; daily pill shows promise in reducing HbA1c; mavacamten misses in nonobstructive HCM trial and the FDA clears smart belt device reduce fall injury.

Uplizna gains new indication; Vanrafia approved for proteinuria in IgAN; Erzofri now available for schizophrenia; setmelanotide shows promise in hypothalamic obesity; GLP-1RAs may reduce dementia risk.  

New treatments for Prader-Willi Syndrome and hemophilia; FDA fast tracks a chlamydia vaccine candidate; over-the-counter test cleared for identifying chlamydia, gonorrhea and trichomoniasis; semaglutide improves walking ability in patients with peripheral artery disease; and Imfinzi combo therapy approved for MIBC.    

New antibiotic has been approved for uncomplicated UTIs; Cabometyx approved for advanced neuroendocrine tumors; new rosacea treatment option; Tremfya gains Crohn disease indication; Department of HHS cuts 10,000 jobs. 

Influenza vaccine recommendations made for upcoming season; a patient dies following Elevidys infusion; Chikungunya vaccine now available and recommended for those traveling to areas with an outbreak; novel Alzheimer disease treatment launches; risk evaluation and mitigation strategies removed for hypertension treatment.

First Xolair biosimilar approved, Wearable furosemide loop diuretic gains expanded indication; Implant approved for macular telangiectasia; Novel treatment shows promise in hypertension; And testing reveals high benzene levels in over-the-counter acne treatments.

Labeling changes for testosterone products; food allergy treatments compared; FDA approves stroke Tx; COVID-19, flu vaccine effectiveness for recent season; Neffy 1mg approved

REMS requirement removed for schizophrenia treatment; new copper intrauterine device approved; Wegovy, Ozempic no longer in short supply; stem cell therapy for chronic lumbar disc disease fast tracked; ecopipam shows promise for Tourette syndrome.

New vaccines to protect against meningococcal disease and chikungunya virus; skin prep product recalled due to fungal contamination; rapid-acting insulin biosimilar approved; and twice-yearly lenacapavir gets FDA's priority review for HIV PrEP.

Study identifies potential treatment strategy for high-threshold peanut allergy; Emblaveo approved for complicated intra-abdominal infections; new tablet formulation of Evrysdi; FDA fast tracks investigational agents for Alzheimer disease and cannabis use disorder.  

FDA say there are reports that diabetes patients are missing critical safety data from their smartphone devices; A wearable continuous apomorphine infusion device has been approved for Parkinson disease 'off' periods; New migraine and pain treatments get the green light; And a study suggest propranolol may cut stroke risk in certain patients.  

Ozempic gains expanded approval; MS treatment gets Boxed Warning added to label; Monotherapy approval granted for treatment resistant depression Tx Spravato; Leqembi gains  maintenance regimen; Enhertu gains new Breast CA indication.  

The FDA has issued a proposal to remove a common decongestant in over the counter products; A follow-up study assesses the efficacy of a schizophrenia treatment; The FDA's Endocrinologic and Metabolic Drugs Advisory Committee panel takes vote on the potential of approving a new diabetes treatment; IV ibuprofen adverse reactions examined; And semaglutide found to improve liver fibrosis.  

Libby Baney, Senior Advisor to ASOP Global and a partner at Faegre Drinker Consulting, talks to MPR about the current state of online pharmacies and what is being done to protect patients. 

Supplies of a significant number of IV solutions have been impacted by Hurricane Helene; First at-home COVID-19/Flu over-the-counter antigen test gains market authorization; DOJ clamp down on fake online pharmacies; Investigational therapy Fast Tracked for treatment resistant depression; and Cologuard Plus gets cleared for colorectal cancer screening. 

The FDA clears capsule that creates sensation of fullness in the stomach; Complete Response Letter issued for gastroparesis treatment; Apple's sleep apnea notification feature gets clearance; Keytruda gains malignant pleural mesothelioma indication; Ebglyss approved for atopic dermatitis