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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.
Apr 24, 2026
The FDA reversed course and said it would review Moderna’s application for a new mRNA-based flu vaccine. The move followed growing concern about federal vaccine policy and came after HHS canceled nearly $500 million in mRNA vaccine contracts.
Apr 07, 2026
President Donald Trump’s April 2, 2026 proclamation sets a 100% Section 232 tariff on certain patented pharmaceuticals and APIs from July 31, 2026. Generics, biosimilars and several specialty categories are exempt, while some companies can qualify for reduced or zero tariffs through onshoring or MFN pricing agreements.
Apr 01, 2026
The FDA has shifted from regulatory ambiguity to coordinated enforcement against compounded oral semaglutide, culminating in a 2026 announcement of intent to take action against non-approved GLP-1 drugs. Hims & Hers Health's 2024 oral semaglutide offering marked the beginning of a broader regulatory reckoning that saw manufacturer pressure, formal shortage declarations, and warning letters targeting compounding practices.
Mar 24, 2026
HHS Secretary Robert F. Kennedy Jr. announces major reorganization centralizing department operations under CMS leadership, while Duke University telehealth program shows 66% reduction in repeat ER visits for older adults who fall.
Mar 20, 2026
The U.S. Department of Health and Human Services formally scrapped its 2025 340B Rebate Model Pilot Program following federal court rulings and issued a new Request for Information on February 13, 2026, seeking stakeholder input on the future of 340B drug pricing.
Mar 14, 2026
Sen. Josh Hawley and Rep. Diana Harshbarger introduced legislation to withdraw FDA approval of mifepristone nationwide, making distribution a federal violation and allowing patients to sue manufacturers.
Mar 14, 2026
AbbVie reported Q4 earnings that beat consensus estimates with $16.62 billion in revenue, while facing competitive setbacks in psoriatic arthritis and Medicare pricing challenges for Botox.
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 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 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.
Feb 27, 2026
The American Medical Association and University of Minnesota's Vaccine Integrity Project are creating an independent vaccine review system after major changes at the CDC raised concerns among public health experts.
Feb 27, 2026
The FDA announced plans to restrict GLP-1 active pharmaceutical ingredients for compounded drugs and combat misleading advertising, following the Trump administration's launch of TrumpRx and ongoing enforcement actions against compounding pharmacies.
Feb 25, 2026
Industry leaders highlight advances in AI-enabled trial monitoring, real-world data interoperability, and protocol-driven eSource systems, while emphasizing the need for community engagement in diversity efforts and addressing operational risks in rare disease trials.
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 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
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.
