Related coverage linked through entity extraction aliases.
May 13, 2026
The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
May 05, 2026
The global antibody drug conjugate market is calculated at USD 14.76 billion in 2026 and is expected to reach USD 32.66 billion by 2035. North America held a 53% share in 2025, while Asia Pacific is projected to grow fastest.
May 02, 2026
FDA released its 2026 Rare Disease Hub Strategic Agenda and a draft guidance on 3-year New Clinical Investigation Exclusivity. The agency also outlined new pathways including the plausible mechanism pathway and Rare Disease Evidence Principles to accelerate treatments for rare diseases.
Apr 14, 2026
The Consolidated Appropriations Act, 2026 extends the FDA’s rare pediatric disease priority review voucher authority through Sept. 30, 2029. The law also requires a GAO report on the program’s effectiveness.
Mar 28, 2026
The FDA will now allow drug approval based on a single pivotal trial instead of two, a policy change confirmed in a New England Journal of Medicine paper. The new guidance maintains requirements for confirmatory evidence and focuses on trial design quality, aiming to reduce development costs and speed drugs to market. FDA officials argue this approach may actually improve standards by concentrating scrutiny on a single well-designed study.
Mar 12, 2026
The FDA issued reforms on January 11, 2026, loosening chemistry, manufacturing, and control requirements for cell and gene therapy products to advance innovation and accommodate the unique complexity of these treatments.
Mar 11, 2026
The FDA has established a "plausible mechanism pathway" to approve personalized genome editing and RNA-based therapies for rare and ultra-rare diseases without requiring large randomized controlled trials, streamlining access to individualized treatments.
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 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 25, 2026
The FDA has announced a major policy shift ending the "two-trial dogma," allowing drug approvals based on one adequate and well-controlled study plus confirmatory evidence, with heightened focus on study design quality.
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
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 24, 2026
The FDA issued draft guidance establishing a plausible mechanism framework for approving individualized therapies targeting ultra-rare diseases when randomized controlled trials are not feasible due to small patient populations.
Feb 24, 2026
The FDA released draft guidance establishing a new approval framework for individualized gene-editing and RNA-based therapies targeting ultra-rare diseases, allowing approvals based on small studies when traditional trials are not feasible.
Feb 24, 2026
Federal regulators unveiled a new regulatory approach to accelerate approval of personalized genetic treatments for rare, life-threatening conditions, allowing smaller studies when traditional large-scale trials aren't practical while maintaining post-market safety oversight.
Feb 20, 2026
The FDA will now require a single pivotal clinical trial as the default for novel medicine approvals, replacing its decades-old two-trial standard. The policy aims to reduce development costs and accelerate innovation.
Feb 19, 2026
The FDA announced it will generally require only one pivotal trial for drug approvals, ending the decades-old two-trial standard. The policy aims to reduce development costs and speed market access while maintaining focus on trial quality.
Feb 19, 2026
The FDA will host Rare Disease Day 2026 on February 23, focusing on patient engagement and accelerating treatment development. The agency released its 2026 Strategic Agenda for the Rare Disease Hub, outlining new regulatory pathways and coordination efforts.
Feb 17, 2026
The FDA has agreed to review Moderna's mRNA influenza vaccine application after initially rejecting it, following modifications by the company. A decision is expected by August 5, 2026.
