The FDA has issued a proposal to remove a common decongestant in over the counter products; A follow-up study assesses the efficacy of a schizophrenia treatment; The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee panel takes vote on the potential of approving a new diabetes treatment; IV ibuprofen adverse reactions examined; And semagl…

Libby Baney, Senior Advisor to ASOP Global and a partner at Faegre Drinker Consulting, talks to MPR about the current state of online pharmacies and what is being done to protect patients.

Supplies of a significant number of IV solutions have been impacted by Hurricane Helene; First at-home COVID-19/Flu over-the-counter antigen test gains market authorization; DOJ clamp down on fake online pharmacies; Investigational therapy Fast Tracked for treatment resistant depression; and Cologuard Plus gets cleared for colorectal cancer screeni…

The FDA clears capsule that creates sensation of fullness in the stomach; Complete Response Letter issued for gastroparesis treatment; Apple’s sleep apnea notification feature gets clearance; Keytruda gains malignant pleural mesothelioma indication; Ebglyss approved for atopic dermatitis

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 show…

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 …

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 pyelonephriti…

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 …

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.

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.

Biogen discontinue Alzheimer treatment; The American Academy of Dermatology issue new acne vulgaris management guidelines; Update for ongoing availability of Paxlovid; Narcolepsy/ADHD treatment recalled for containing wrong drug; FDA warn against copycat eye drop products

T-cell malignancies prompt label changes for certain T-cell immunotherapies; Novel opioid provides in-built protection against overdose; Hypocalcemia risk with Prolia; At-Home semen insemination kit cleared; New asthma rescued medicine approved

Gene therapy approved for beta thalassemia; treatment for preventing of chronic inflammatory demyelinating polyneuropathy relapse; device to aid dermatologist referrals; vertebral strength device for low-bone mass; Narcan shelf-life extension

Researchers examine link between diabetes, obesity treatments and suicidal ideation; topical treatment for molluscum contagiosum; IV bags recalled following discovery that they may contain twice as much of the labeled drug; update on the penicillin shortage; newly cleared test measures HbA1c from menstrual blood.…

An expert panel rank the 30 best diets for 2024; Counterfeit Ozempic on the rise; Myasthenia gravis drug approved; Herpes tests may produce false positives; Safety concerns over IV promethazine hydrochloride.

Topical gel approved to treat partial thickness wounds in epidermolysis bullosa; Priority Review given to 21-valent pneumococcal conjugate vaccine; sensory and motor stimuli video game for ADHD gains expanded age approval; on-demand HIV prevention for women; multiple food allergy drug

The ADA release their new guidance for the management of diabetes 2024; a new blood collection device obtains lab-quality samples using a the finger; novel treatment for postpartum depression becomes available; a study for a male birth control pill begins; and a Public Benefit Corporation seeks approval for an MDMA-assisted therapy.…

Novel weight loss treatment now available in pharmacies; Novo Nordisk warns about the risks of compounded semaglutide; treatment approved for paroxysmal nocturnal hemoglobinuria; over-the-counter insemination kit cleared by the FDA.

Safety alert issued for serious reactions to certain seizure drugs; Drug approved to treat a rare form of tumor; T-cell malignancies reported with cell immunotherapies; organ transplant rejection treatment recalled; CPAP machine associated with reports of burns and fires.

First chikungunya vaccine approved; FDA send warning letter to Amazon about ophthalmic products; at-home STD test cleared; Bayer withdraw lymphoma drug; and a combo treatment to reduce catheter-related bloodstream infections is approved.

New weight management approved; Novo Nordisk discontinue Levemir; adjunctive system for hypertension patients; frontotemporal dementia treatment given Fast Track designation; and the FDA advise against use of glucose supplement.

FDA urge immediate discontinuation for eye drop products; safety alert issued for the pediatric Moderna COVID-19 vaccine; novel heartburn medicine approved; Stelara biosimilar approved; and an antibody to prevent fentanyl overdose gets fast tracked.

New pentavalent meningococcal vaccine approved; Gohibic’s shelf-life extended by 6 months; maintenance treatment approved for adults with moderately to severely active ulcerative colitis or Crohn disease; self-administered option for FluMist Quadrivalent accepted for review; intravenous combo formulation of acetaminophen and ibuprofen approved for …

FDA approves a novel treatment for major depressive disorder; vote taken on stem cell therapy for ALS; preservation-free Iyuzeh now available; CDC recommends RSV vaccine for during pregnancy; investigational treatment shows promise in familial chylomicronemia syndrome.

Bacterial pneumonia treatment now available; FDA deny proposed anaphylaxis treatment; Results on flu vaccine efficacy; More flexible dosing for Talicia; Change in the therapeutic equivalence for organ rejection drug generic.

The FDA and CDC greenlight updated COVID-19; prescription drug for dry eye disease now available; head-to-head study comparing Skyrizi to Stelara for Crohn disease; the REMS program has been updated for IBS treatment Lotronex; and the FDA cracks down on companies selling unnaproved eye products.

With fall on the horizon, MPR sat down with Assistant Professor of Clinical Pharmacy at the University of California San Diego, Dr. Abdul-Mutakabbir. Our wide ranging talk covers the updated COVID-19, flu and RSV vaccines. We also discuss vaccine hesitancy, health equity and representation in medicine.…

New vaccine guidelines issued for the 2023-2024 flu season; USPSTF make recommendations on PrEP prescribing; maternal RSV vaccine; updated COVID vaccine shows strong immune response; new treatment approved for rare immune disease.