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Jul 15, 2026
The FDA now defaults to a single pivotal trial for drug approvals, replacing the two-trial standard. Critics warn it could approve ineffective drugs. A draft guidance covers individualized therapies.
Jun 23, 2026
FDA Commissioner Marty Makary resigned on May 12, 2026, after a 13-month tenure, leaving many informal policy initiatives vulnerable to reversal. Acting Commissioner Kyle Diamantas now leads the agency amid leadership turnover and industry calls for stability.
Jun 15, 2026
FDA reinstates top vaccines regulator ten days after abrupt departure, drawing criticism from public health experts and far-right commentators. Departure was tied to Duchenne muscular dystrophy treatment and COVID-19 vaccine controversies.
May 15, 2026
The FDA's January draft guidance proposes MRD-negative complete response as an accelerated approval end point for multiple myeloma drugs. It defines MRD negativity, sets trial design requirements, and accepts comments through March 23, 2026. Expert Nicholas Richardson discusses calibration challenges and the single-trial model.
Jul 21, 2026
The FDA has approved Tregzi, a donor-derived T-cell immunotherapy, to reduce the risk of chronic graft-versus-host disease following stem cell transplant in adults with high-risk blood cancers. In a pivotal trial, 78% of recipients were alive and free of severe chronic GVHD at one year versus 38.4% with standard transplant.
Jun 20, 2026
The FDA reversed its initial rejection of Moderna's mRNA flu vaccine, agreeing to a normal review after public backlash, while a federal judge invalidated the ACIP advisory committee, leaving the US without functioning vaccine oversight. Moderna's vaccine showed 26.6% greater efficacy than standard flu shots in clinical trials.
Jun 15, 2026
The FDA has granted accelerated approval to Denali Therapeutics' Avlayah (tividenofusp alfa-eknm), the first therapy targeting neurological symptoms of Hunter syndrome. The approval was based on a surrogate endpoint measuring heparan sulfate reduction in cerebrospinal fluid, with confirmatory study results required for full approval. The global Hunter syndrome treatment market is projected to reach $2.6 billion by 2033.
Jun 11, 2026
Disc Medicine has agreed with the FDA to resubmit bitopertin for rare blood disorder erythropoietic protoporphyria, with the agency allowing the Phase 3 APOLLO trial to support a new filing. The agreement follows a February rejection and could lead to a mid-2027 decision. Disc has implemented workforce cuts and its CFO sold shares amid the regulatory setback.
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.
