MPR Weekly Dose

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in children with diabetes; a major depressive disorder therapy gains fast track status; and Tecentriq has an indication withdrawn.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.

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. 

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.

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.

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.  

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.

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.

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.

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.

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.

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.

The FDA Advisory Committee vote on Novavax; new option for MMR vaccination; Dupixent approval expanded; and we take a look at the latest data on COVID-19 treatments.

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.

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.