MPR Weekly Dose

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

New drug approved to treat ulcerative colitis; Once-weekly insulin efsitora investigated in type 1 diabetes; Dupilumab shows efficacy for treating urticaria; A twice-yearly injection shows potential for treating severe asthma; and GSK calls an end to their development of a herpes vaccine.

CDC Advisory Committee issue vaccine guidelines for flu season; Smallpox vaccine gains expanded indication; Updated Novavax COVID-19 vaccine; Over-the-counter gel for erectile dysfunction; New inserter system for placement of contraceptive intrauterine system.

Genentech decide to remove Fuzeon from US market; Rybrevant and Lazcluze approved as first-line treatment for certain patients with EGFR-mutated advanced NSCLC; FDA warning regarding unapproved potassium phosphates; Otezla approval expanded to include treatment of pediatric patients; Results from tirzepatide diabetes risk reduction study.

New Treatment for Primary Biliary Cholangitis; Nemluvio approved for prurigo nodularis; FDA Denies MDMA for PTSD; New hypoparathyroidism treatment; First digital therapeutic approved for depression.

The FDA give an updated on the availability of obesity drugs; The CDC has issued an updated guideline on contraceptive use; The first T-cell gene therapy is approved for synovial sarcoma; Lymphir gains approval for relapsed or refractory cutaneous T-cell lymphoma; Fabhalta gains a new indication.

FDA voice concerns over compounded semaglutide; New treatment approved for mild to moderate dementia of the Alzheimer type; Colorectal cancer screening test gets green light; Leqselvi approved for alopecia; And peanut allergy treatment gains expanded indication.

Duchenne muscular dystrophy treatment now available; Noise therapy wearable for nasal congestion; Treatment for delaying diabetes gets Fast Tracked; Soliris biosimilar approved; And the first orally-disintegrating contraceptive.

Seizure medication recalled due to wrong strength on carton; Gene therapy gains Fast Track status for Parkinson disease; Dendritic cell vaccine being developed for pancreatic cancer; Generic version of sickle cell disease treatment Endari is made available

New steroid-free topical for atopic dermatitis; A refillable ocular implant for the treatment of  neovascular (wet) age-related macular degeneration returns following recall; A neuroimmune modulation device shows clinical benefit in adults with rheumatoid arthritis; FDA denies Novo Nordisk's once-weekly insulin icodec; And a smarthphone therapy shows benefit for patients with fibromyalgia.

New maintenance treatment approved for COPD; Authorized generic version of Victoza launches; Duchenne muscular dystrophy treatment indication expanded; Narcolepsy treatment expanded for certain pediatric patients; FDA clears digital therapeutic for ADHD.  

Skyrizi has been approved for ulcerative colitis; New pneumococcal vaccine approved; An indictment may impact as much as 50,000 patients who need ADHD meds; Results announced for Moderna's next-gen COVID-19 vaccine; Farxiga approval expanded.

Two glucose monitoring systems have been cleared for over-the-counter sale; Arexvy gains approval for adults aged 50 to 59 years; Kevzara approved for active polyarticular juvenile idiopathic arthritis; Generic Duchenne muscular dystrophy drug is made available; and Iqirvo gets accelerated approval for primary biliary cholangitis.