MPR Weekly Dose

Treatment granted Emergency Use Authorization for hospitalized COVID-19 patients; Preterm-birth prevention treatment withdrawn from market; Sleep device for infants gets green light for marketing; New Padcev plus Keytruda indication; Mail-back system for unused opioids; Opioid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

FDA Committee take vote on possible OTC Narcan; Rebyota available to prevent CDI recurrence; Risk of maternal sepsis lowered with azithromycin; Cinbinqo indication expanded; Topical treatment shows promise for hand eczema

Type 2 diabetes treatment discontinued; Depression, postpartum treatment gets Priority Review; Hypothyroid treatment recalled; FDA warns about weight loss supplement; First retinopathy of prematurity treatment for preterm infants approved.

The FDA make major revisions to COVID-19 antiretrovirals; Large study finds possible new indication for beta blockers; Jesduvroq approved; Artificial tears product recalled; Evusheld emergency use authorization halted.

Pfizer-BioNTech bivalent vaccine under investigation; Trial evaluating HIV prevention vaccine discontinued; Early detection sepsis test cleared; Trial results for RSV-associated disease vaccine; Combo Tx for HCC recurrence shows promise

FDA grant accelerated approval to Alzheimer disease treatment; New fixed-dose asthma treatment; NERD therapy looks promising; Leukemia drug to be withdrawn; Pertussis prevention treatment approved for use during pregnancy

Risk evaluation and mitigation strategy updated for abortion pill, mifepristone; Potential PTSD therapy shows positive results; A host of HIV meds are to be discontinued in the next year; Weight-loss treatment gains expanded approval in pediatrics; Experts rank their best diets for a variety of categories. 

In this week's episode we interviewed Gretel Schueller, managing editor of health at US news, to discuss the results from this year's Best Diet rankings and the methodology used to compile the list.

Interim guidance for influenza treatment with limited oseltamivir; FDA panel vote on omecamtiv mecarbil; Tecentriq gains new indication; Potential combo COVID-19 and influenza vaccine; Detect COVID-19 tests recalled.

New authorization for COVID-19 vaccines in certain children; Narcan nasal spray to be reviewed for OTC status; Empagliflozin assessed in children with diabetes; a major depressive disorder therapy gains fast track status; and Tecentriq has an indication withdrawn. 

FDA pull bebtelovimab; compounding guidance issued in light of the amoxicillin shortage; the first fecal microbiota treatment is approved; a treatment for Alzheimer disease agitation shows promise; and a gene therapy for duchenne muscular dystrophy is accepted for Priority Review.

Newly approved gynecologic cancer treatment; Zejula has it's use restricted; intrauterine system use extended; a second insulin product is approved as a biosimilar to Lantus; and an FDA Advisory Committee take a vote on tenapanor.

USPSTF recommendations on estrogen and progesterone; semaglutide assessed in obese teenagers; efficacy and safety data released for maternal RSV vaccine; updates to clozapine REMS; FDA panel vote on investigational CNS/leptomeningeal metastasis treatment.

Approvals for relapsed or refractory multiple myeloma, non-radiographic axial spondyloarthritis, and unresectable hepatocellular carcinoma; advisory committee takes vote on potential treatment for anemia of chronic kidney disease; and an oral formulation of pulmonary arterial hypertension treatment.

FDA Panel votes on the potential removal from the market of Makena; results from an apixaban trial of patients with atrial fibrillation and valvular heart disease; reports of serious ocular complications with monkeypox infection; the novavax vaccine becomes the latest authorized COVID-19 booster; and treatments for nephropathy and ALS have their review period extended.

Bivalent COVID-19 booster vaccines for children; wearable device to help treat fluid overload in adults with chronic heart failure; real-world data insights into molnupiravir efficacy; vaccine for the third trimester of pregnancy to prevent pertussis; and an FDA update on apomorphine infusion in Parkinson disease. 

ALS treatment news; Evusheld fact sheet update; an at-home epilepsy diagnostic aid gets cleared; drug recalls; and a laser therapy for fibromyalgia.

This week we go over warnings about a new social media challenge; treatment approvals in cisplatin-associated ototoxicity, cerebral adrenoleukodystrophy, MRI contrast agents and a generic version of tazorac. 

Approvals in psoriasis, hepatorenal syndrome, and neutropenia; novel therapy gains Priority Review for Rett Syndrome; and the effects of multivitamin supplementation assessed on cognitive function.  

Hello listener and welcome to episode 130 of the MPR Weekly Dose Podcast. This week we have news of the FDA's vote on an ALS treatment; CPAP and BiPAP device recalls; Orphan Drug designation for a novel CRISPR therapy; Imfinzi gains new approval; and Spevigo is approved for pustular psoriasis flares.