Policy & Regulation


  • A photo of FDA CBER Director Peter Marks delivering remarks at a public workshop on March 3, 2020.
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    Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
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    Peter Marks, former top FDA vaccine official, joins Eli Lilly

    Six months after his abrupt resignation as CBER director, Marks has been hired to run discovery and infectious disease work at the big Indianapolis drugmaker.

    By Jonathan Gardner • Oct. 8, 2025
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    As setbacks plague other companies, MindMed becomes a front-runner in the psychedelics race

    Challenges faced by other drugmakers have reinforced, rather than discouraged, MindMed’s approach to psychedelic drug R&D for anxiety and other disorders.

    By Alexandra Pecci • Oct. 7, 2025
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    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
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    Win McNamee via Getty Images
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    Trump administration could lower drug prices by making other nations pay more

    The Trump administration often touts its efforts to lower prices in the U.S. by matching what other countries pay, but there’s more to this policy story.

    By Kelly Bilodeau • Oct. 6, 2025
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    AstraZeneca’s at-home flu vaccine is a breakthrough that could pave the way for others

    FluMist Home could be a test case for at-home vaccines against a backdrop of challenging regulatory shifts.

    By Alexandra Pecci • Oct. 1, 2025
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    Top pharma industry conferences in 2026

    Where pharma leaders will converge, discuss and navigate the industry’s shifting landscape in 2026.

    By Oct. 1, 2025
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    Is pharma’s IRA pricing battle running out of steam?

    Despite recent court losses, the legal tides could still turn in the industry’s favor.

    By Sept. 26, 2025
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    With DTC ads under fire, pharma companies need to pivot

    An executive order from HHS doesn’t prohibit direct outreach to consumers, but drugmakers will need to rethink their outreach strategies.

    By Kelly Bilodeau • Sept. 22, 2025
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    3 FDA approval firsts that could be around the corner

    Several market-altering decisions are on the agency’s docket for the rest of 2025.

    By Sept. 19, 2025
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    Andrew Harnik via Getty Images
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    At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves

    Robert F. Kennedy Jr. faced criticism Thursday even from Republican lawmakers over changes to federal vaccine policy as well as a leadership crisis at the CDC.

    By Delilah Alvarado , Jonathan Gardner • Sept. 5, 2025
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    International appeal: Europe and UK lure US scientists with financial incentives

    With slashed budgets and decimated research programs, American scientists are increasingly looking for career opportunities abroad.

    By Alexandra Pecci • Sept. 4, 2025
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    Why drugmakers may need to borrow from quantum theory to confront tariff and pricing threats

    With so many unknowns surrounding regulatory and policy shifts, pharma companies might need to consider fundamental changes to how they operate, a Deloitte analyst said.

    By Sept. 3, 2025
  • Boxes of COVID-19 vaccines from Pfizer and Moderna sit side by side.
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    Joe Raedle via Getty Images
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    FDA approves updated COVID boosters, but narrows use

    In a post on X, HHS Secretary Robert F. Kennedy said the FDA has cleared vaccines from Pfizer, Moderna and Novavax for use in "high risk" individuals.

    By Delilah Alvarado • Updated Aug. 27, 2025
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    Sarah Silbiger via Getty Images
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    Why an FDA decision for a new drug could ripple through the ultra-rare disease space

    All eyes are on Stealth BioTherapeutics as it awaits a long-delayed approval for its first-in-class treatment for Barth syndrome.

    By Alexandra Pecci • Aug. 26, 2025
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    Anna Moneymaker via Getty Images
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    FDA’s new accelerated pathway could open pharma up to risks, as well as benefits

    Faster review times will leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty in the drug approval process.

    By Amy Baxter • Aug. 25, 2025
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    Andrew Harnik via Getty Images
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    MAHA leaders may take aim at pharma DTC advertising

    RFK Jr. has his sights set on increasing advertising enforcement against pharmas, but may not come down as hard on the industry as previously thought.

    By Amy Baxter • Aug. 20, 2025
  • Boxes of the diabetes drug Ozempic rest on a pharmacy counter on April 17, 2023 in Los Angeles, California.
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    Mario Tama / Getty via Getty Images
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    Despite FDA ruling, compounded GLP-1s are still giving Novo and Lilly headaches on the market

    Copycat weight loss drugs were supposed to be pulled from the market, but pharmacies have found a loophole. 

    By Amy Baxter • Aug. 18, 2025
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    With scrapped mRNA funding, a vaccine maker finds a silver lining

    While mRNA is suffering the brunt of the MAHA movement with $500 million in funding cuts, other vaccine makers could fill some of that void.

    By Aug. 14, 2025
  • President Donald Trump speaks to reporters at the the Lehigh Valley International Airport on Aug. 3, 2025, in Allentown, Pennsylvania.
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    Anna Moneymaker via Getty Images
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    With FDA PreCheck, drugmakers may get a manufacturing boost

    The newly announced program targeting domestic manufacturing is the latest Trump administration move to ramp up drugmaking in the U.S.

    By Amy Baxter • Aug. 13, 2025
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    Puerto Rico’s ongoing journey from manufacturing hub to innovation enterprise

    Biotechs are coming to the island as tariffs threaten overseas drug exports, and finding Puerto Rico is more than just a leading manufacturing hub.  

    By Aug. 12, 2025
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    Are stem cell therapies ready for pharma’s prime time?

    Stem cell therapies are thriving on the fringes of healthcare — but science-backed treatments are also poised to make an impact in pharma R&D.

    By Kelly Bilodeau • Aug. 11, 2025
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    As gene therapies falter on the market, this biopharma is aiming to defy the odds

    After a strong launch for its cancer gene therapy, Ferring Pharmaceuticals is setting the stage for long-term growth.

    By Aug. 8, 2025
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    PBM reform was dropped from Trump’s spending bill. It could have saved billions.

    The Senate nixed a provision to “delink” drug list prices from compensation for PBMs and other drug middlemen days before its passage.

    By Alexandra Pecci • Aug. 6, 2025
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    Drugmakers score policy win in a prolonged fight against 340B

    A new pilot program from HHS would alter the contentious 340B pricing program by swapping traditional upfront drug discounts for rebates.

    By Amy Baxter • Aug. 4, 2025
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    Retrieved from Vinay Prasad on May 08, 2025
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    Dr. Vinay Prasad, controversial FDA official, abruptly departs agency

    Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office got embroiled in controversy over a Duchenne gene therapy.

    By Ben Fidler • July 30, 2025
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    E+ via Getty Images
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    From the bench: Researchers make NIH-funded preclinical strides in mRNA and obesity

    The studies are contributing preclinical advances for some of the world’s biggest blockbusters.

    By July 25, 2025