MPR Weekly Dose Podcast #292 — Daridorexant in Pediatric Insomnia; Novel Huntington Disease Tx; vadadustat assessed TIW in anemia CKD; Voceryq accelerated approval; zanubrutinib combo for MCL
This week, we break down 5 pivotal regulatory decisions. This includes FDA actions for daridorexant in pediatric insomnia and a gene therapy for Huntington disease, alongside an accelerated approval f...
6 Nov 12min
MPR Weekly Dose Podcast #290 — Weltruza, Hovilpri Approved, Atezolizuman Regimens for Stage III dMMR Colon CA; Subcutaneous Tx for TED; Vanda’s Anxiety Tx Falls
Recent regulatory and clinical developments include the approval of Weltruza — the first once-monthly subcutaneous long-acting formulation of olanzapine for schizophrenia — as well as the first subcut...
16 Okt 13min
MPR Weekly Dose Podcast #289 — Juvmo for Parkinson Disease; Camzyos Approval Expanded; MS Treatment Gains Priority Review; Sudden BLA Withdrawal for a Key Lung Cancer Candidate
New FDA approvals for Juvmo in Parkinson disease and Camzyos in pediatric obstructive hypertrophic cardiomyopathy, a Priority Review green light for fenebrutinib in MS, and the sudden BLA withdrawal f...
2 Okt 12min
MPR Weekly Dose Podcast #288 — CagriSema Weight Loss Results; ALS Treatment Shows Promise; Primary IgA Nephropathy Tx; Gene Therapy Approved for Sanfilippo Syndrome; Lyrfigtu Approved
Results for weight loss treatment combo cagrilintide and semaglutide; positive results for treatment of rare form of ALS, and for sefaxersen in adults with primary IgA nephropathy; gene therapy approv...
25 Sep 12min
MPR Weekly Dose Podcast #287 — Approvals for SMA and CKD; Joenja Approval Expanded; LSD Breakthrough in Depressive Disorder; Zasocitinib in Plaque Psoriasis
Approvals for spinal muscular atrophy and chronic kidney disease; Joenja gains expanded approval in APDS; LSD derivative earns Breakthrough status to treat major depressive disorder; and zasocitinib i...
18 Sep 13min
MPR Weekly Dose Podcast #286 — Alexander Disease Tx; Hyrnuo and Etcamah Approved; Pelacarsen Misses Endpoint; Atogepant Shows Promise in Menstrual Migraines
First treatment approved for Alexander disease; Hyrnuo and Etcamah are approved for lung cancer and breast cancer, respectively; Pelacarsen misses endpoint in the phase 3 HORIZON trial, and atogepant ...
11 Sep 13min
MPR Weekly Dose Podcast #285 — Mounjaro Approval Expanded; Updated RSV Pediatric Recs; Remibrutinib Shows Promise for Relapsing MS; Boxed Warning Added to Injectafer PI
Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in...
4 Sep 11min
MPR Weekly Dose Podcast #285 — Mounjaro Approval Expanded; Updated RSV Pediatric Recs; Remibrutinib Shows Promise for Relapsing MS; Boxed Warning Added to Injectafer PI
Mounjaro approval expanded to reduce the risk of major cardiovascular events; The American Academy of Pediatrics has issued updated recommendations for RSV immunization; BTK inhibitor shows promise in...
4 Sep 11min
