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Aug 22, 2026
HRSA announced a revised 340B Rebate Model Pilot Program effective January 1, 2027, letting manufacturers use rebates instead of upfront discounts. Rebate plans are due August 24, 2026.
Jul 31, 2026
Lawmakers opened national security probes into Merck, AbbVie and others over China drug trials. A survey finds China closing in on U.S. biotech leadership, and HHS launched clinical trial reforms to counter the rise.
Aug 08, 2026
FDA approved Moderna's mFLUSIVA, the first mRNA-based flu vaccine for adults 50+. It was 27% more effective than standard flu shots in a large trial. The approval came after earlier FDA pushback.
May 27, 2026
The FDA replaced the two-trial approval requirement with a single pivotal trial standard, launched an AI pilot with AstraZeneca and Amgen, and extended the camizestrant review. A key FDA official is departing. AstraZeneca posted $58.74 billion in revenue.
May 28, 2026
The Trump administration barred NIAID officials from WHO meetings, reclaimed $600M from four states, and faced a Senate report showing drug prices rising despite deals. New drugs average $353K a year.
Jun 02, 2026
GE HealthCare expanded a BARDA deal by $35M for AI ultrasound; Wavelet Medical partnered with Aegis Ventures to advance AI fetal EEG. Both aim to improve diagnostic speed and accuracy.
Aug 08, 2026
FDA issued EUAs for Dectomax and CLiK Extra against New World screwworm. Dectomax is for prevention/treatment in dairy cattle, swine, horses, sheep, deer. CLiK Extra prevents myiasis in livestock, camelids, wildlife.
Apr 05, 2026
Biotech investors are closely watching cystic fibrosis drug trials, rare-disease therapies and regulatory catalysts. Sionna Therapeutics is advancing a new CF drug class, while Praxis Precision Medicines targets essential tremor. FDA staffing challenges add uncertainty to approval timelines.
Jul 08, 2026
CDC suppressed COVID-19 vaccine data; federal agencies may remove vaccines from the US market. Clinicians cite a JAMA study: 40% efficacy against hospitalization, 79% against severe outcomes.
Jul 28, 2026
The European Commission granted marketing authorization to Sandoz for Bysumlog (insulin lispro) and Dazparda (insulin aspart), two biosimilar insulins developed by Gan & Lee Pharmaceuticals. A recent HHS analysis found most biosimilar markets become economically unviable after five competitors, prompting companies to diversify portfolios. Accord aims to bring 20 biosimilars to market by 2030.
Aug 01, 2026
The Senate HELP Committee advanced a bill to streamline biosimilar approvals by relying on analytical tests, potentially cutting development costs and time. The FDA has issued guidance removing comparative efficacy studies and is working to speed post-exclusivity approvals. Combined with administration support and PBM reforms, these moves aim to increase biosimilar competition and reduce drug prices.
Jul 20, 2026
The Agency for Healthcare Research and Quality has cut off continuing funding for at least 73 projects, totaling over $102 million in committed funds. HHS says the move serves the federal government's best interest, but researchers warn that mid-stream grant freezes waste already-spent money and threaten the training of future health-care scientists.
Jul 03, 2026
The FDA will allow food makers to claim "no artificial colors" as long as dyes are not petroleum-based, even if products contain titanium dioxide. Health experts warn the labeling deceives consumers, as naturally derived additives like titanium dioxide pose health risks and remain unregulated.
Jun 24, 2026
HHS launches broad initiative to boost US clinical trials amid global competition with China. FDA introduces real-time clinical trial monitoring and expedited programs. NIH Long COVID trials set to begin enrolling participants in summer 2026.
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 16, 2026
HHS and CMS issued a proposed rule to codify the Medicare Drug Price Negotiation Program, largely formalizing existing guidance. The rule includes new provisions, such as clarifications for new drug formulations. The proposal is now open for public comment.
Jun 06, 2026
Long COVID patients continue to suffer as federal research funding and support programs have been dramatically scaled back, with the Office of Long COVID Research and Practice closed and NIH grants disrupted. The chronic condition affects as many as a third of COVID-19 survivors with over 200 possible symptoms, yet experts say the disease remains difficult to research amid politicization. Medical professionals warn that reduced resources undermine diagnosis, treatment, and the professional pipeline for new research.
May 18, 2026
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
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.
Apr 28, 2026
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
