MPR Weekly Dose

New drug approved to treat ulcerative colitis; Once-weekly insulin efsitora investigated in type 1 diabetes; Dupilumab shows efficacy for treating urticaria; A twice-yearly injection shows potential for treating severe asthma; and GSK calls an end to their development of a herpes vaccine.

CDC Advisory Committee issue vaccine guidelines for flu season; Smallpox vaccine gains expanded indication; Updated Novavax COVID-19 vaccine; Over-the-counter gel for erectile dysfunction; New inserter system for placement of contraceptive intrauterine system.

Genentech decide to remove Fuzeon from US market; Rybrevant and Lazcluze approved as first-line treatment for certain patients with EGFR-mutated advanced NSCLC; FDA warning regarding unapproved potassium phosphates; Otezla approval expanded to include treatment of pediatric patients; Results from tirzepatide diabetes risk reduction study.

New Treatment for Primary Biliary Cholangitis; Nemluvio approved for prurigo nodularis; FDA Denies MDMA for PTSD; New hypoparathyroidism treatment; First digital therapeutic approved for depression.

The FDA give an updated on the availability of obesity drugs; The CDC has issued an updated guideline on contraceptive use; The first T-cell gene therapy is approved for synovial sarcoma; Lymphir gains approval for relapsed or refractory cutaneous T-cell lymphoma; Fabhalta gains a new indication.

FDA voice concerns over compounded semaglutide; New treatment approved for mild to moderate dementia of the Alzheimer type; Colorectal cancer screening test gets green light; Leqselvi approved for alopecia; And peanut allergy treatment gains expanded indication.

Duchenne muscular dystrophy treatment now available; Noise therapy wearable for nasal congestion; Treatment for delaying diabetes gets Fast Tracked; Soliris biosimilar approved; And the first orally-disintegrating contraceptive.

Seizure medication recalled due to wrong strength on carton; Gene therapy gains Fast Track status for Parkinson disease; Dendritic cell vaccine being developed for pancreatic cancer; Generic version of sickle cell disease treatment Endari is made available

New steroid-free topical for atopic dermatitis; A refillable ocular implant for the treatment of  neovascular (wet) age-related macular degeneration returns following recall; A neuroimmune modulation device shows clinical benefit in adults with rheumatoid arthritis; FDA denies Novo Nordisk's once-weekly insulin icodec; And a smarthphone therapy shows benefit for patients with fibromyalgia.

New maintenance treatment approved for COPD; Authorized generic version of Victoza launches; Duchenne muscular dystrophy treatment indication expanded; Narcolepsy treatment expanded for certain pediatric patients; FDA clears digital therapeutic for ADHD.  

Skyrizi has been approved for ulcerative colitis; New pneumococcal vaccine approved; An indictment may impact as much as 50,000 patients who need ADHD meds; Results announced for Moderna's next-gen COVID-19 vaccine; Farxiga approval expanded.

Two glucose monitoring systems have been cleared for over-the-counter sale; Arexvy gains approval for adults aged 50 to 59 years; Kevzara approved for active polyarticular juvenile idiopathic arthritis; Generic Duchenne muscular dystrophy drug is made available; and Iqirvo gets accelerated approval for primary biliary cholangitis.

First generics of heart failure drug gain approval; mRNA vaccine approved for RSV; CDC make drug recommendation for STI prevention; Advisory Committee vote on MDMA for PTSD; Rinvoq approval expanded

Extended-release ADHD treatment gains approval; An interchangeable biosimilar to Soliris is approved; Investigational treatment shows promise for improving depression and insomnia; The FDA vote on a blood-based colorectal cancer diagnostic; Survey reveals public attitudes towards the FDA.

Self-administered device cleared to treat stress urinary incontinence in women; Autoinjector warning for relapsing MS treatment; COVID-19 preexposure prophylaxis investigational treatment looks promising; Biosimilars for Eylea approved; Imdelltra approved for extensive stage small cell lung cancer with disease progression.  

Reliability of COVID-19 tests unreliable; Insulin pump app updated following battery issue; Noninvasive colorectal cancer test gets FDA approval; Self-collection HPV screening option; National Drug Threat Assessment highlights illicit drugs currently endangering the US. 

Dr. Michael Ganio, ASHP's Director of Pharmacy Practice and Quality, joins me to discuss the current drug shortage crisis, which has reached new levels.

Dr Charles Raison, the Director of Clinical Research at the Usona Institute and Professor in the Department of Psychiatry at the University of Wisconsin–Madison, joins me to discuss the potential of psilocybin as a therapy for major depressive disorder.

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.

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.  

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.  

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.  

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

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. 

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.