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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.
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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.
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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.…
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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.…
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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.
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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.
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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.
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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for those with knee osteoarthritis; Prescribing Information labeling updated for opioids; Imbruvica indications withdrawn; Patch to combat excessive underarm sweating given green light; Novel treatment Fast Tracked for Type A and B influenza.
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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…
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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…
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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.
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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.…
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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.
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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.…
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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
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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.
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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.
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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
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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
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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.…
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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.
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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.
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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.
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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.
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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.
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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.
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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 re…
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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.…
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ALS treatment news; Evusheld fact sheet update; an at-home epilepsy diagnostic aid gets cleared; drug recalls; and a laser therapy for fibromyalgia.
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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.
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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.
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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.…
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Omicron-adapted COVID-19 booster vaccines; guidance for the 2022-23 influenza season; efficacy of COVID-19 antiviral; ‘rainbow fentanly’ targeting youth; and a device to treat chronic idiopathic constipation.
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USPSTF recommendations on the use of statins for primary prevention of cardiovascular disease; At-home visual acuity test; A new treatment for major depressive disorder; Novavax COVID-19 vaccine approved for adolescents; And there is an alert regarding the potential risk of transmission of monkey virus through fecal microbiota transplantation.…
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Novavax vaccine booster update; over-the-counter hearing aids; priority review for a castration-resistant prostate cancer combination treatment; a first gene therapy approved for beta-thalassemia; FDA urges repeat at home COVID-19 testing to reduce risk of missing infection.
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New authorization for intradermal administration of monkeypox vaccine; a new approval for endometriosis pain; Amazon is among the companies to receive an FDA Warning Letter for selling unapproved drugs; a diabetes drug is found to contain a possible carcinogen; and a new scale that measures peripheral impedance and pulse rate.…
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A neurostimulation device has been cleared for post-C-section pain; a new plaque psoriasis treatment; the FDA address the contrast agent shortage; Lucentis biosimilar treatment is approved; and the recall for an over-the-counter laxative is expanded.
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Novavax Emergency Use authorization; the Pfizer-BioNTech vaccine gets approval in adolescents; submission for oral contraceptive to be switched to over the counter; Astepro nasal spray gets over-the-counter approval; and Dupixent shows benefits in pediatric patients with eosinophilic esophagitis.
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Pharmacists now allowed to prescribe Paxlovid; new dosing recommendations for Evusheld; abuse-deterrent opioid analgesic; priority review for early alzheimer disease treatment; morphine tablets recalled.
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New nasal spray for allergic rhinitis; weight management drug indication is expanded to include teens; monkeypox vaccine access; COVID-19 antibody shelf-life extension; JUUL banned in the US.
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Skyrizi gains new approval; the USPSTF make recommendations on multivitamin use to prevent CVD and cancer; an FDA Panel vote on pimavanserin efficacy for treating hallucinations associated with Alzheimer disease psychosis; Phexxi analysed in over 1000 patients; and Vaxneuvance approved for some pediatrics.…
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FDA panel vote on COVID vaccines for young children; new drug approved to treat alopecia; paxlovid tested in standard risk individuals; a device to aid autism diagnosis; and a new approval for polyneuropathy hATTR.
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Ukoniq, a treatment just approved last year, has been withdrawn; We rundown a host of drug pipeline news in asthma, dermatology and oncology; and there's positive results for a novel postpartum depression treatment.
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The latest guidance for Paxlovid treatment following rebound reports; Dupixent gets a new approval; A new treatment is approved for plaque psoriasis; Update on the efficacy of a COVID-19 vaccine in those aged under 5; And the latest on Monkeypox.
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The FDA decide to decline COVID-19 treatment; Booster doses authorized for children; A direct to consumer test to detect COVID-19, influenza, and RSV; And a wearable furosemide delivery system accepted for review.
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Treatment approved for hospitalized COVID-19 patients; Update on Varenicline supply; Limits have been set for the Janssen COVID-19 vaccine; Safety alert issued for a COVID-19 test; And certain hemodialysis machines may carry the potential for chemical exposure.
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This week: USPSTF recommendations on aspirin use to prevent cardiovascular disease; Veklury indication expanded; Accupril Lots recalled; Legal action on counterfeit HIV medication; And the White House releases plan to tackle the overdose epidemic.
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This week: the halting of the sabizabulin trial in COVID-19; Emergency Use Authorization to be requested for booster dose in 5 to 11 year olds; Diversity in Clinical Trials; Myopericarditis risk compared for COVID-19 vaccines vs other vaccines; And survey results of unvaccinated attitudes following FDA approval.…
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