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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.
Feb 26, 2026
Four biotech companies went public in one week raising nearly $1 billion, signaling a potential thaw in IPO markets after years of quiet activity. Regional life sciences hubs outside Boston and San Francisco are attracting record venture funding, while regulatory uncertainty at FDA continues to concern industry leaders.
Feb 26, 2026
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
Feb 26, 2026
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
Feb 25, 2026
Moderna partners with Recordati on propionic acidemia therapy for up to $160 million, while FDA Commissioner defends mRNA vaccine support following funding cuts and regulatory challenges.
Feb 24, 2026
Moderna and Merck are recruiting patients for a Phase 2 trial testing V940, an mRNA-based cancer vaccine, combined with Keytruda and chemotherapy as first-line treatment for metastatic squamous non-small cell lung cancer.
Feb 24, 2026
The FDA reversed its decision to reject Moderna's mRNA influenza vaccine application, accepting it for review one week after an initial refusal-to-file that reportedly involved senior leaders overruling staff advice.
Feb 23, 2026
BioNTech filed a patent infringement lawsuit against Moderna in Delaware federal court, alleging the company's newly approved mNEXSPIKE vaccine uses proprietary mRNA technology without authorization.
Feb 17, 2026
Moderna faces a pivotal transition from pandemic-era revenues to a diversified mRNA portfolio, with recent regulatory setbacks offset by strong RSV vaccine performance and upcoming Phase 3 oncology readouts.
