Policy & Regulation


  • President Trump holding up an executive order on vaccines.
    Image attribution tooltip
    Anna Moneymaker via Getty Images
    Image attribution tooltip

    Trump signs order seeking to upend childhood vaccine schedule

    The executive order — which wasn’t accompanied by any new scientific evidence — aims to split the MMR vaccine into three separate shots and revives the administration’s attempt to slim down the immunization schedule.

    By Delilah Alvarado • Aug. 11, 2026
  • tariffs
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Large pharmas skirt tariffs; BMS’ dealmaking drought

    Big Pharmas won't get hit new levies on branded drugs; and aside from the megamerger rumors, BMS has had a relatively quiet year for M&A.

    By PharmaVoice Staff • Aug. 7, 2026
  • Trendline

    Artificial intelligence & machine learning

    After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.

    By PharmaVoice staff
  • A picture of CDC director Erica Schwartz testifying at a Senate confirmation hearing.
    Image attribution tooltip
    Finn Gomez / Staff via Getty Images
    Image attribution tooltip

    Erica Schwartz confirmed as next CDC director

    Schwartz will step into an agency that has been without a permanent leader for almost a year amid RFK Jr.’s tumultuous tenure as HHS chief. 

    By Kristin Jensen • Aug. 6, 2026
  • Corporate logo for AstraZeneca, whose megamerger talks with BMS were scrapped
    Image attribution tooltip
    Christopher Furlong / Staff via Getty Images
    Image attribution tooltip

    What the AstraZeneca-BMS rumors reveal about pharma megamergers

    Reports of talks were quickly disputed, but the prospect exposed the appeal — and antitrust risks — of combining two pharma giants.

    By Kelly Bilodeau • Aug. 6, 2026
  • FDA magnifying glass
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    FDA allows unique endpoint in rare disease study

    Global regulators are allowing the company to use hospitalization as the primary efficacy endpoint in its registration trial for a rare neuromuscular disorder.

    By Alexandra Pecci • Aug. 5, 2026
  • Trump tariffs
    Image attribution tooltip
    Chip Somodevilla via Getty Images
    Image attribution tooltip

    Trump has another tariff plan to reshore generic drug production. Will it work?

    The president’s most recent tariff proposal gives pharma more time to transition its global supply chain and reshore generic drug production.

    By Kelly Bilodeau • Aug. 3, 2026
  • dna helix
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Genetic clues for cell therapy toxicities; Summit’s high-stakes FDA decision

    Researchers have pinpointed genes linked to dangerous CAR-T cell therapy side effects, and a predictions market weighs in on Summit’s closely-watched cancer drug.

    By PharmaVoice Staff • July 31, 2026
  • Kalshi
    Image attribution tooltip
    Scott Olson via Getty Images
    Image attribution tooltip

    Kalshi is expanding online betting in drug R&D — unless detractors can stop it

    Kalshi sees drug development predictions as a way to improve R&D transparency. Critics say they could create financial incentives around research and undermine public trust.

    By Susanna Vogel • July 28, 2026
  • A person in a lab coat is seen through a well-lit, organized laboratory environment featuring shelves stocked with additional lab supplies and instruments.
    Image attribution tooltip
    Alamy
    Image attribution tooltip

    The FDA was all in on AI. Will that change?

    High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

    By Kelly Bilodeau • July 24, 2026
  • psychedelic pill
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Lilly’s leap into psychedelics; peptides in the spotlight

    Eli Lilly is extending its push in neuroscience while the FDA wrestles with controversial peptide drugs. 

    By PharmaVoice Staff • July 24, 2026
  • FDA sign
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    What’s in the FDA’s latest batch of rejection letters

    A look at two recent CRLs demonstrate the tension and discrepancies between how companies and the agency communicate drug rejections.

    By Alexandra Pecci • July 23, 2026
  • Dr. Marty Makary speaks at a press conference.
    Image attribution tooltip
    Andrew Harnik via Getty Images
    Image attribution tooltip

    Why the FDA’s top spot could sit empty for months

    Multiple factors could get in the way of confirming a new commissioner before the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.

    By Susanna Vogel • July 22, 2026
  • A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland.
    Image attribution tooltip
    Sarah Silbiger via Getty Images
    Image attribution tooltip

    What policies could last — or could get axed — amid leadership churn at FDA

    How new review policies, the use of AI and other recent FDA changes are being impacted by high turnover at the top.

    By Kelly Bilodeau • July 10, 2026
  • paperwork art
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    HHS plan to speed drug R&D won’t remove ‘self-inflicted’ delays

    U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?

    By Kelly Bilodeau • July 8, 2026
  • FDA magnifying glass
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    HHS, responding to China’s rise, moves to fast-track early drug research

    A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.

    By Jonathan Gardner • June 24, 2026
  • hand shake
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    As M&A rebounds, here’s how pharmas can prepare to seal a deal

    Drugmakers that aren’t ready when financial opportunity knocks could get caught flat-footed in a competitive market.

    By Kelly Bilodeau • June 18, 2026
  • china flag pill
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Amid a flurry of biotech deals, China looks to keep innovation at home

    The country's new regulatory pathway promises to accelerate access to advanced therapies for Chinese patients, but may change the licensing game for foreign companies.

    By Kelly Bilodeau • June 10, 2026
  • Bottles of Bristol Myers Squibb's Cobenfy, a new drug for schizophrenia, are arranged in this photo illustration.
    Image attribution tooltip
    Permission granted by Bristol Myers Squibb
    Image attribution tooltip

    BMS under pressure in schizophrenia; Summit/Akeso on a winning streak

    While the large pharma’s new drug Cobenfy has stumbled in schizophrenia, it could find new life in Alzheimer’s disease

    By PharmaVoice staff • June 5, 2026
  • capitol china flag
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    House bill aims to crack down on China biotech deals

    A proposal to add biotechnology to the COINS Act follows two big deals involving Pfizer and Bristol Myers, and comes amid U.S. fears that China’s drugmaking progress may threaten national security.

    By Kristin Jensen • June 4, 2026
  • ISS
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    When the ISS comes down, will its drug R&D be lost in space?

     As NASA prepares to bring its hallmark space lab back to Earth, a host of private companies are emerging to fill the gap.

    By June 3, 2026
  • gold pills
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Can AI crack pharma’s drug repurposing goldmine?

    With AI now capable of analyzing decades’ worth of data, FDA is pushing pharma to leverage its “enormous, untapped value” by repurposing drugs.

    By Alivia Kaylor • May 29, 2026
  • FDA chaos
    Image attribution tooltip
    Getty Images
    Image attribution tooltip

    Can a chaotic FDA still deliver on faster drug development?

    As leadership changes create more instability at the agency, here's what it'll take to keep speedier drug approvals on track. 

    By Kelly Bilodeau • May 26, 2026
  • Patroski Lawson
    Image attribution tooltip
    Permission granted by American Biotech Innovation Alliance
    Image attribution tooltip
    Q&A

    China’s biotech rise sparks new US industry alliance

    The nonprofit is aiming to inspire a new moonshot effort that helps the U.S. maintain its position as a drug innovation leader.

    By Kelly Bilodeau • May 21, 2026
  • Vaccine
    Image attribution tooltip
    Alex Wong via Getty Images
    Image attribution tooltip

    Sanofi’s vaccine bump; the new FDA commish

    A look at how vaccine makers are scraping by, and at the incoming acting FDA head, Kyle Diamantas.

    By PharmaVoice staff • May 15, 2026
  • Jeremy Levin
    Image attribution tooltip
    Permission granted by Ovid Therapeutics
    Image attribution tooltip
    Q&A

    Former Ovid CEO Dr. Jeremy Levin’s rallying cry for biotech

    The long-time pharma exec is on a quest with a new book and bold message for biotech leaders and U.S. lawmakers.

    By May 15, 2026