Policy & Regulation
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Biopharma CEO optimism is wavering in the US
The overall leadership outlook was positive in a recent survey but varied between executives in the U.S. and those overseas.
By Kelly Bilodeau • Dec. 22, 2025 -
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3 key takeaways from the FDA’s new animal testing guidance
The agency’s moves to end animal testing are “not a fluke.” Here’s what drugmakers need to know about where it goes from here.
By Alexandra Pecci • Dec. 17, 2025 -
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TrendlineArtificial 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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How the FDA could soon upend vaccine trials
Vaccinemakers should be prepared to pivot to meet new requirements by ensuring strong communication.
By Kelly Bilodeau • Dec. 17, 2025 -
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5 CDER directors in one year? Turnover threatens ‘institutional memory’ at US health agencies.
Rapid movement among regulators’ top brass has contributed to an inconsistent strategic direction — but there’s hope in bureaucracy.
By Michael Gibney • Dec. 16, 2025 -
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After years of debate, the Biosecure Act could be headed for Trump’s desk
The revised version of the bill softens compliance burdens between U.S. pharma firms and Chinese suppliers, but still has teeth.
By Kelly Bilodeau • Dec. 15, 2025 -
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Standout drug approvals in 2025
Despite ongoing turbulence at the FDA, pharma has delivered several notable breakthroughs to the market.
By Kelly Bilodeau • Dec. 8, 2025 -
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FDA conflicts of interest extend beyond adcomm experts
Many speakers at public meetings report conflicts while showing support for new drugs, according to recent analysis.
By Meagan Parrish • Dec. 5, 2025 -
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4 major changes at the FDA this year
The most impactful regulatory shifts for pharma in 2025 and how the industry can take advantage of new policies.
By Alexandra Pecci • Dec. 3, 2025 -
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Along with NIH cuts come risks to patient safety and scientific data
The abrupt withdrawal of research funds affected 74,000 clinical trial participants, including some already taking the drugs being studied.
By Kelly Bilodeau • Nov. 26, 2025 -
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4 takeaways from pharma’s manufacturing boom
As pharma’s U.S. facility investments top $370 billion over the next five years, there are a few things to keep in mind, according to construction experts.
By Alexandra Pecci • Nov. 25, 2025 -
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Pharma faces a critical ‘turning point’ in 2026, years in the making
While Trump’s manufacturing and pricing deals with pharma shape the industry’s future, COVID’s impact still ripples throughout the health landscape.
By Michael Gibney • Nov. 21, 2025 -
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FDA unveils new regulatory roadmap for bespoke drug therapies
The “plausible mechanism” pathway, outlined by Dr. Martin Makary and Dr. Vinay Prasad, is designed to help accelerate treatments custom-made for individuals with rare and serious diseases.
By Ben Fidler • Nov. 13, 2025 -
Permission granted by Sarepta Therapeutics
Drugs are winning approval even when trials fail — but should they?
About 10% of FDA-approved drugs in recent years have won clearance despite a trial failure, raising safety and ethical concerns.
By Kelly Bilodeau • Nov. 12, 2025 -
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Tariffs, pricing, backroom deals — how pharma can navigate wildly shifting policies
Gaming out new regulations and various potential outcomes will help keep companies on more solid footing.
By Kelly Bilodeau • Nov. 3, 2025 -
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How Trump’s do-or-die agenda is impacting Big Pharma’s CEO chatter
Among tariffs, pricing policies and ongoing negotiations, pharma leaders can’t help but address their dealings with the Trump administration in third-quarter earnings reports.
By Michael Gibney • Oct. 30, 2025 -
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Massachusetts biotech hub is limping amid layoffs and low investment
The state’s difficulties in the last year are indicative of wider industry problems during a time of market trepidation, as optimism gives way to resilience.
By Michael Gibney • Oct. 23, 2025 -
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Why a treatment older than the FDA is getting new regulatory scrutiny
MAHA-aligned patients and providers are pushing back to ensure access to an animal-derived thyroid hormone treatment.
By Kelly Bilodeau • Oct. 20, 2025 -
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Pregnant women, long excluded from drug trials, are back in the spotlight
The White House has raised concerns around women’s health, but R&D on pregnant and breastfeeding women is still lacking.
By Meagan Parrish • Oct. 17, 2025 -
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Ultra-rare diseases got a boost from recent FDA approval signalling more regulatory flexibility
Stealth BioTherapeutics’ FDA win could help build momentum in the broader rare disease space.
By Alexandra Pecci • Oct. 15, 2025 -
Ermath, Michael. (2020). "Individualized Therapies Workshop" [Photograph]. Retrieved from Flickr.
Dr. 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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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 Meagan Parrish • 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 Meagan Parrish • Sept. 26, 2025
