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; Significant moves in COVID-19 vaccine development; Research finds a link between PPI use and increased risk of COVID-19; We look at remdesivir’s efficacy in severe COVID-19 cases; And several Company’s recall their metformin extended release tablets.