MPR Weekly Dose 199 — Fasenra Expanded Approval; HIV Tx Approval Expanded; ALS Drug Discontinued; CRL for Apomorphine Device; At-Home Mpox Test
MPR Weekly Dose
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.
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MPR Weekly Dose 198 — Prescription App for MDD; Traumatic Brain Injury Blood Test; New Bloodstream Infection Antibiotic; Mpox Vaccine Availability; Left Ventricular Ejection Fraction Detection
MPR Weekly Dose
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.
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MPR Weekly Dose 197 — Pemgarda Emergency Use; Expansion of Nexletol, Nexlizet; DMD Drug Approval; First Molecular Malaria Blood Test; OTC Topical Analgesic Warning
MPR Weekly Dose
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.
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MPR Weekly Dose 196 — Chronic Rhinosinusitis Nasal Spray; Novel hypertension Tx; Stem-Cell Treatment Approved for Rare Disease; Accelerated approval for NASH Tx; Automated Insulin Delivery System
MPR Weekly Dose
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.
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MPR Weekly Dose 195 — Weight Loss Tx Gains Cardiovascular Indication; Paxlovid Update; Psilocybin Granted Breakthrough Therapy; Decision Delay for Alzheimer Tx; Relyvrio Trial Results
MPR Weekly Dose
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
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MPR Weekly Dose 194 — OTC Birth Control Pill; First OTC Continuous Glucose Monitor; Influenza Vaccine for 2024/2025 Season; Breakthrough Therapy for LSD; Biosimilars to Prolia and Xgeva
MPR Weekly Dose
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 approved.
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MPR Weekly Dose 193 — Pepaxto Approval Withdrawn; Abrysvo Efficacy; Ixchiq Vaccine Recommendations; Novel Schizophrenia Tx Decision; UTI Tx Approval; Eye Ointment Recalled
MPR Weekly Dose
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 pyelonephritis; over-the-counter eye ointments recalled.
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MPR Weekly Dose 192 — Xolair Approved for Multiple Food Allergies; Amtagvi Gets Approval; Vit D Supplement Recalled; Cannabidiol for Pericarditis; Smartwatch Warning
MPR Weekly Dose
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 glucose.
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MPR Weekly Dose 191 — First FDA-Approved Tx for Frostbite; New Eosinophilic Esophagitis Tx; Psychoactive Accepted for Review for PTSD; Novel Tx for Prurigo Nodularis; OTC Oximeter
MPR Weekly Dose
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.
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MPR Weekly Dose 190 — Nonopioid Pain Med; Dental Pain Management; Arexvy Review; Magrolimab Development Ended; Athlete’s Foot Spray Recalled
MPR Weekly Dose
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.
info_outlineThis week we cover the latest COVID-19 developments including a triple antiviral therapy that looks promising, Emergency Use Authorizations granted to diagnostics and critical meds, Moderna’s investigational vaccine gets Fast Tracked, and the National Institute of Health’s remdesivir plus baricitinib trial.