May 15, 2026 | FDA's CDER Chief Høeg Expected to Exit; Tecentriq Wins Bladder Cancer Approval

Jun 19, 2026 | US Probes Germany Drug Pricing; Moderna Flu Vaccine Wins Unanimous FDA Panel

US government opens formal probe into Germany's drug pricing reforms, escalating transatlantic pharma trade tensions. Kardigan IPO raises $400M and pops 31%. Moderna flu vaccine gets unanimous FDA advisory panel support ahead of Aug 5 PDUFA. Jazz and AbCellera strike $4.1B T cell engager collaboration. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Germany drug pricing, US trade probe, Moderna flu vaccine, mFlusiva, Kardigan IPO, Jazz Pharmaceuticals, AbCellera, T cell engagers, Pfizer CFO Dave Denton, Eli Lilly, 4E Therapeutics, Edgewise Biosciences, HCM, Biogen, RayThera, Traws Pharma, tivoxavir marboxil, Merck Capvaxive, Treasury China biotech, cAMPfield, Vedana Therapeutics, Spot Bio, Innoviva, Lyndra, Sanofi, Aurobindo, Lannett, Pfizer, Lilly, Merck, Moderna

Jun 18, 2026 | Moderna mFlusiva Wins Unanimous VRBPAC Vote; NovoCure TRIDENT Fails in GBM

Moderna's mRNA flu vaccine gets unanimous FDA panel backing — PDUFA August 5. NovoCure's TRIDENT trial misses overall survival in glioblastoma; stock drops ~18%. Biogen acquires immunology startup RayThera for up to $1B; Kardigan IPO raises $400M. Visit us at www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, Moderna, mFlusiva, MRNA, VRBPAC, mRNA flu vaccine, NovoCure, NVCR, TRIDENT, glioblastoma, TTFields, Biogen, BIIB, RayThera, immunology, Pfizer, PFE, CFO, Kardigan, IPO, cAMPfield, Legend Biotech, LEGN, Carvykti, Eli Lilly, 4E Therapeutics, Merck, Capvaxive, pneumococcal vaccine, Innoviva, Lyndra, Aurobindo, Lannett, FTC, Treasury, China biotech, Lilly, GSK, Sanofi

Jun 17, 2026 | UniQure AMT-130 Surges 70% on FDA Reversal; Jazz-AbCellera $4.1B TCE Deal

UniQure surges 70% as FDA reverses course on Huntington's gene therapy AMT-130 filing path. Jazz and AbCellera strike $4.1B T cell engager deal for GI cancers. Novo Nordisk faces $25M ransom demand after hackers claim drug formulations and AI models.   Visit www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, UniQure, QURE, AMT-130, Huntington's disease, gene therapy, FDA accelerated approval, Jazz Pharmaceuticals, AbCellera, T cell engagers, Novo Nordisk, cyberattack, data breach, Biogen, RayThera, immunology, Moderna, mFlusiva, VRBPAC, mRNA flu vaccine, GSK, Spero Therapeutics, complicated UTI, compounded GLP-1, Vedana Biosciences, Spot Bio, Triveni Bio, Colorado drug importation

Jun 16, 2026 | BridgeBio BBP-418 Sweeps LGMD Phase 3; FDA Scrutinizes Moderna Flu Vaccine

BridgeBio's BBP-418 sweeps Phase 3 in limb-girdle muscular dystrophy — stock up 15%, no approved competition. FDA briefing docs challenge Moderna mFlusiva efficacy ahead of Thursday's VRBPAC vote. Plus Lilly acquires non-opioid pain startup 4E Therapeutics, Edgewise advances EDG-7500 toward Phase 3 in HCM, and Neumora abandons navacaprant after two Phase 3 failures. Visit www.thepharmacloseput.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, BridgeBio, BBP-418, LGMD, limb-girdle muscular dystrophy, Moderna, mFlusiva, VRBPAC, flu vaccine, Eli Lilly, 4E Therapeutics, non-opioid pain, MNK inhibitor, Edgewise, EDG-7500, HCM, hypertrophic cardiomyopathy, Adaptive Biotechnologies, MRD, Neumora, navacaprant, myelofibrosis, Jakafi, Be Biopharma, enGene, Parabilis, biotech IPO, Colorado drug import, Lilly, Novartis

Jun 15, 2026 | CMS Targets SubQ Keytruda and Opdivo Loophole; Takeda Beats Sotyktu Head-to-Head

CMS proposes closing Medicare negotiation loophole threatening Keytruda and Opdivo subcutaneous strategies — billions at stake. Plus Takeda's zasocitinib tops Sotyktu, Novartis validates $12B Avidity deal, Elicio's KRAS vaccine crashes, and FDA approves Truqap in prostate cancer and Tzield for pediatric T1D. Visit us at www.thepharmacloseout.com pharma, pharmaceutical, FDA, clinical trials, biotech, drug approvals, healthcare, pharma podcast, The Pharma Closeout, CMS, Medicare drug price negotiation, IRA, Keytruda, pembrolizumab, Opdivo, nivolumab, subcutaneous, Merck, Bristol Myers Squibb, Takeda, zasocitinib, Sotyktu, deucravacitinib, TYK2, Novartis, Avidity Biosciences, del-brax, RNA therapeutics, Elicio Therapeutics, KRAS, cancer vaccine, ELI-002, pancreatic cancer, AstraZeneca, Truqap, capivasertib, prostate cancer, PTEN, Sanofi, Tzield, teplizumab, type 1 diabetes, Welireg, belzutifan, kidney cancer, J&J, Talvey, Darzalex Faspro, multiple myeloma, Summit Therapeutics, ivonescimab, oveporexton, narcolepsy, SLEEP 2026, Gan & Lee, bofanglutide, obesity, GLP-1, Eisai, Leqembi, Lilly, BMS