Apr 02, 2026
The FDA will drop its longtime requirement for two rigorous studies to approve new drugs, moving to a default position of requiring only one study. Commissioner Marty Makary says the change reflects modern scientific advances and aims to accelerate drug availability without compromising safety. The shift follows decades of increasing flexibility for rare and fatal diseases, with about 60% of first-of-a-kind drugs already approved based on single studies in recent years.
Mar 28, 2026
Moderna shares declined nearly 6% amid extreme options market volatility and a new patent infringement lawsuit from BioNTech. The company faces significant financial challenges with negative earnings and declining revenue growth, while valuation metrics suggest potential overvaluation. Technical indicators point to bearish short-term momentum as the stock approaches key support levels.
Mar 28, 2026
Moderna will pay $2.25 billion to settle patent disputes with Arbutus Biopharma and Genevant Sciences over lipid nanoparticle technology used in its COVID-19 vaccine. The settlement removes uncertainty for Moderna's vaccine pipeline and sent the stock surging over 11%. The company expects to end 2026 with $4.5-$5 billion in cash and return to revenue growth by year-end.
Mar 21, 2026
Moderna reported Q4 revenues of $678 million, down 29.8% year-over-year but beating analyst expectations. The FDA reversed course and will review the company's mRNA flu vaccine application.
Mar 20, 2026
DelveInsight pipeline reports reveal robust clinical development across three cancer indications, with 45+ companies advancing cutaneous squamous cell carcinoma therapies, 70+ companies developing liver cancer treatments, and multiple hepatocellular carcinoma candidates receiving FDA designations in 2025-2026.
Mar 14, 2026
GSK's RSV vaccine Arexvy received expanded FDA approval to cover all high-risk adults, adding approximately 21 million Americans under 50 to the eligible population and matching competitor approvals from Pfizer and Moderna.
Mar 13, 2026
Moderna's stock shows mixed signals with recent gains offset by multi-year declines. Valuation models suggest shares may be overvalued on some metrics while analysts maintain Hold ratings with downside price targets.
Mar 12, 2026
Multiple institutional investors modified their Moderna Inc positions during recent quarters, with some funds increasing stakes while others reduced or exited positions, according to 13F filings.
Mar 12, 2026
Federal vaccine advisers have dropped a plan to reconsider mRNA COVID-19 vaccine recommendations amid Republican concerns about midterm election impacts. The committee maintains its September 2025 decision on shared clinical decision-making.
Mar 12, 2026
New research from 18 countries shows COVID-19 vaccination during pregnancy, particularly with booster doses, significantly reduces the risk of preeclampsia and other serious complications for both mothers and babies.
Mar 07, 2026
Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, will depart the agency by the end of April to return to an academic role at the University of California San Francisco.
Mar 07, 2026
The FDA has denied or discouraged at least eight drug applications in the past year, including treatments for rare diseases, raising concerns about regulatory consistency and the future of experimental therapies.
Mar 04, 2026
Moderna has settled with Arbutus and Genevant, facing a potential $1.3 billion liability contingent on Federal Circuit's decision. Multiple institutional investors have increased their stakes in the biotech company during recent quarters.
Mar 03, 2026
Health Secretary Robert F. Kennedy Jr. is drawing criticism from anti-vaccine supporters who believe he has not gone far enough in dismantling vaccine programs, following regulatory reversals including the restoration of an mRNA flu shot review.
Mar 03, 2026
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
Mar 02, 2026
Moderna's mRNA-1010 seasonal influenza vaccine enters FDA review following a revised approach that splits approval pathways by age group, with a decision expected by August 2026.
Feb 27, 2026
The FDA reversed an earlier refusal and agreed to review Moderna's seasonal flu vaccine application after the company revised its approach based on age groups, setting a decision date of August 5, 2026.
Feb 27, 2026
Moderna announced UK authorization for its updated Spikevax vaccine targeting the LP.8.1 variant and European Commission marketing authorization for mNEXSPIKE, its third vaccine approved in the EU.
Feb 18, 2026
A House Energy and Commerce subcommittee hearing on Feb. 11 revealed sharp partisan divisions over drug pricing solutions, with Republicans focusing on PBM reform and supply chain transparency while Democrats defended existing price negotiation policies and warned of threats from research funding cuts.
Feb 24, 2026
The FDA's Center for Biologics Evaluation and Research issued a refusal-to-file letter to Moderna for its investigational influenza vaccine mRNA-1010, citing concerns over the Phase 3 trial control arm and whether it reflected the best-available standard of care.
