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Ionis wins first FDA nod for Alexander disease
PLUS: Xenotransplant patients get human kidneys, lung cancer drug tops Keytruda, and Ultragenyx cuts costs after trial failure
Novartis, BMS halt autoimmune CAR-T trials on safety
PLUS: Lilly's Mounjaro wins CV nod, Takeda scores rare cancer approval, and a $2.9B immunology buyout
Revolution's pancreatic cancer drug wins FDA approval
PLUS: AstraZeneca's heart drug failure raises class concerns, Cytokinetics scores cardiomyopathy win, Priovant lands rare disease nod
Court backs Medicare drug pricing vs. Merck, AZ
PLUS: FDA halts Regenxbio gene therapy again, RFK Jr. seeks vaccine input, Moderna-Merck cancer vaccine success
Moderna-Merck cancer vaccine posts landmark Phase 3 win
PLUS: Ultragenyx scores first gene therapy approval, Regeneron wins FDA nod for ultra-rare bone disease, Trump taps Overton for FDA chief
BMS wins first CELMoD drug approval for myeloma
PLUS: Amylyx scores with GLP-1 blocker, Argenx expands Vyvgart franchise, and IRS probes UnitedHealth
Lilly sues 6 firms over retatrutide black market
PLUS: Psychedelic pill shows promise for anxiety, Neurocrine faces safety concerns, and Commure halts AI referral payments
Trump orders overhaul of pediatric vaccine schedule
PLUS: Jazz acquires epilepsy drugmaker for $1.3B, Sionna's cystic fibrosis drug fails trial, FDA mandates food additive notices
FDA approves first mRNA flu vaccine from Moderna
PLUS: Replimune wins melanoma therapy approval after two rejections, Takeda's first-in-class narcolepsy drug, and a clinical trial death in China
Curium Acquires Lantheus for $8B in Radiopharma Deal
PLUS: BioNTech names new CEO, AstraZeneca-BMS merger speculation heats up, and Amgen reports major cybersecurity breach
J&J bets $2.6B on in vivo CAR-T tech
PLUS: FDA panel backs Replimune's melanoma therapy, Medicaid work rules proceed, FTC sues Hims & Hers
Sarepta taps ex-AbbVie exec Severino as new CEO
PLUS: Argenx's $2.2B Forte acquisition, FDA approves Otsuka's ADHD drug Simtriyo, and Alzheimer's trial shows safety promise
FDA panel backs unapproved peptides in narrow vote
PLUS: GSK's lung cancer drug approval, Lilly's obesity treatment advances, and Trump's generic drug tariff threat
Novo sues Lilly over GLP-1 ads; Tempus buys for $1.5B
PLUS: Bristol Myers builds AI supercomputer, Samsung Biologics eyes peptide maker, and telehealth safety concerns emerge
Merck wins FDA nod for first oral PCSK9 pill
PLUS: Lilly's $2.8B psychedelics bet, Medicare's AI payment overhaul, and prediction markets hit clinical trials
Padcev-Keytruda Combo Wins FDA Nod for Bladder Cancer
PLUS: Sanofi's first on-body injector for cancer, FDA's Zyn authorization under scrutiny, and a pancreatic cancer breakthrough
AstraZeneca, Ionis heart drug fails Phase 3 trial
PLUS: FDA approves Vera's kidney disease treatment, White House reviews FDA commissioner finalists, and Roche ends Huntington's programs
Vertex acquires Crinetics for $10B in biotech boom
PLUS: FDA expands gene therapy to toddlers, telehealth GLP-1 prescriptions lack oversight, and Amgen recalls nearly 1M heart medication bottles
Roche KRAS drug beats rival in lung cancer trial
PLUS: FDA approves Orca Bio's cell therapy, Anthropic enters drug development, and Colorado's price cap blocked
26 States Sue to Block Medicaid Work Requirements
PLUS: FDA approvals reshape TED and gout markets, Zymeworks acquires Theravance for $929M, and AstraZeneca settles kickback charges
Supreme Court Overturns Roundup Cancer Verdict
PLUS: Gilead's Trodelvy wins FDA approval for triple-negative breast cancer, Merck KGaA acquires Bio-Techne for $11.3B, WHO launches Ebola treatment trial
AbbVie Bets $11B on Apogee's Autoimmune Pipeline
PLUS: China approves first CAR-T for solid tumors, Lilly cuts 340B discounts, and FDA reverses gene therapy rejection
Moderna's mRNA flu shot wins FDA panel backing
PLUS: Ebola outbreak escalates in Africa, gene therapy advances for Huntington's disease, and biotech IPO market heats up
FDA Approves Colorado's Canada Drug Import Plan
PLUS: Medicare targets subcutaneous cancer drugs, Merck wins kidney cancer approval, AI transforms neurology trials
Parabilis breaks IPO record with $670M raise
PLUS: Takeda's psoriasis drug beats Bristol Myers in head-to-head trial, Novartis RNA therapy succeeds, Medicare Advantage plans face scrutiny
RXDELTA Healthcare Digest
Trump strips job protections from NIH leadership
PLUS: Ebola treatment access authorized amid research cuts, ADC Therapeutics trial deaths, Supreme Court skinny label ruling
Revolution's RAS drug shows unprecedented pancreatic results
PLUS: Trump overhauls vaccine schedule, ASCO delivers multiple cancer breakthroughs, Ebola vaccine funding accelerates
GSK hepatitis B drug achieves functional cure in 20%
PLUS: CVS restores Lilly obesity drug coverage, AstraZeneca faces FDA delay, and blood pressure wearables flood market
AstraZeneca's Datroway Wins FDA Nod for Breast Cancer
PLUS: Lilly expands vaccine portfolio, Biogen's Parkinson's setback, and new FDA leadership takes charge
Lilly's Triple-G Drug Matches Bariatric Surgery Results
PLUS: Merck-Kelun lung cancer combo slashes progression 65%, Biogen's Parkinson's setback, and Bristol Myers goes all-in on AI
WHO declares Ebola emergency; U.S. bans travel
PLUS: Supreme Court upholds Medicare drug negotiations, Maryland caps Ozempic prices, and AstraZeneca wins FDA approvals
Regenxbio's Duchenne gene therapy heads to FDA
PLUS: FDA leadership search narrows, BeOne wins lymphoma approval, and Lilly-Novo obesity battle heats up
Trump to Fire FDA Chief Makary
PLUS: Roche acquires AI pathology firm for $750M, Lilly invests $4.5B in manufacturing, Supreme Court extends mifepristone access
Sanofi pulls drug from FDA program after interference
PLUS: Novo's Wegovy pill hits $355M debut, Angelini buys Catalyst for $4.1B, and FDA blocks vaccine safety studies
Supreme Court restores mifepristone access
PLUS: FDA approves first PROTAC cancer drug, UCB acquires bispecifics maker for $2.2B, hantavirus outbreak on cruise ship
Purdue Pharma to Dissolve After Criminal Sentence
PLUS: Trump names new surgeon general nominee, AI outperforms doctors in diagnostics, and $2.6B in pharma deals
Sun Pharma's $11.75B Organon Buyout Tops 2026 Deals
PLUS: Intellia's CRISPR therapy succeeds in pivotal trial, Lilly acquires two innovation-focused companies, and FDA fast-tracks psychedelic treatments
FDA Approves Regeneron Gene Therapy for Hearing Loss
PLUS: Trump's drug pricing deals, Merck's $1B Google AI partnership, and AbbVie's $1.4B North Carolina campus
Trump orders FDA to fast-track psychedelics review
PLUS: Lilly acquires cell therapy firm for $3.25B, CAR-T shows promise in preventing myeloma, and Revolution Medicines' KRAS data
Kailera nets $625M in massive obesity drug IPO
PLUS: Lilly's oral obesity pill clears heart safety hurdle, Roche plans new Elevidys trial, Novartis CEO joins AI board
Merck acquires Terns for $6.7B in oncology bet
PLUS: FDA approves rare disease therapies for Hunter syndrome and ovarian cancer, medical schools drop equity requirements
Pfizer's Lyme vaccine moves forward despite mixed data
PLUS: FDA expands Rhythm's obesity drug, Parkinson's med safety updates, and 22,000+ pharma job cuts in 2025
Lilly's triple-G obesity drug hits Phase 3 milestone
PLUS: Novo's high-dose Wegovy wins FDA approval, J&J's oral psoriasis pill clears regulatory hurdles, and NIH funding crisis deepens
Judge blocks RFK Jr. vaccine policy overhaul
PLUS: Oral GLP-1 pill shows promising weight loss results, GSK expands RSV vaccine, and White House pushes most-favored nation drug pricing
FDA Launches Unified Safety Surveillance System
PLUS: Lilly warns of impurities in GLP-1 knockoffs, commits $3B to China manufacturing, and MedPAC calls out Medicare Advantage overpayments
Vinay Prasad Exits FDA as Biotech Stocks Rally
PLUS: BioNTech founders launch new mRNA venture, Novo strikes Hims deal, and Vertex kidney drug succeeds in trial
Lilly bypasses insurers with employer GLP-1 program
PLUS: Moderna settles COVID vaccine patent fight for $2.25B, FDA cracks down on compounded weight loss drugs
CMS Halts Elevance Medicare Advantage Enrollment
PLUS: FDA approves Ascendis dwarfism drug, UniQure gene therapy setback, AI chatbot gets breakthrough status
Lilly's GLP-1 pill beats Novo's Rybelsus in Phase 3
PLUS: FDA faces Senate scrutiny on rare disease reviews, Sarepta CEO announces retirement, and Generate raises $400M in IPO
Novo's Obesity Drug Fails Against Lilly's Zepbound
PLUS: Gilead's $7.8B Arcellx buy, FDA's gene therapy roadmap, and Merck's oncology split
DOJ sues OhioHealth over anticompetitive contracts
PLUS: Grail's cancer test misses study goal, Supreme Court strikes down tariffs, and Vertex's CRISPR therapy rebounds
FDA reverses course on Moderna's flu vaccine review
PLUS: New standard for drug approvals, psilocybin heads to FDA, and Grail's cancer test setback
Digital Health Integration Transforms Modern Pharmacy Practice
PLUS: AI clinical tools gain traction, remote patient monitoring expands, and pharmacy apps reshape patient engagement
Harm reduction programs gain ADA legal protections
PLUS: AstraZeneca targets 25+ blockbusters by 2030, fentanyl smoking linked to fewer overdoses, Hims faces regulatory scrutiny
Biosimilar Adoption Surges as Patents Expire on Major Biologics
PLUS: New adalimumab biosimilar enters market, oncology biosimilar pipeline expands, and payer formulary shifts accelerate
New CMS Rules Reshape 340B Program Oversight for 2026
PLUS: Hospital outpatient drug spending surges, insulin pricing update, and pharmacy quality measure changes
Independent Pharmacies Fight Back Against PBM Practices
PLUS: FTC releases damning PBM report, state attorney general actions, and pharmacy coalition gains momentum
FDA Accelerates Generic Drug Approvals in Push for Lower Prices
PLUS: New compounding regulations proposed, telepharmacy expansion, and specialty drug pipeline update
CVS Health Restructuring Plan Shakes Up Retail Pharmacy Landscape
PLUS: Walgreens explores going private, generic drug pricing trends, and pharmacy technician shortage deepens
What's Ahead for Pharmacy in 2026: Trends and Predictions
PLUS: New year drug launches, reimbursement outlook, and technology trends to watch
Pharmacy Industry Year in Review: The Biggest Stories of 2025
PLUS: Top drug launches, regulatory milestones, and what shaped pharmacy practice this year
Medicare Part D Changes Bring Relief for Seniors' Drug Costs in 2026
PLUS: Pharmacy deserts expand, biosimilar Humira gains market share, and new antibiotic wins FDA approval
Eli Lilly's Weight-Loss Drug Expansion Signals New Era in Obesity Treatment
PLUS: Novo Nordisk supply chain update, pharmacy benefit reform advances, and CVS earnings surprise