Politicization runs deeper than ever at FDA, risking long-term impacts

Wide-ranging shifts at the FDA have set the stage for decisions that drag the agency through the political mud, according to an economist and public policy expert.

By Michael Gibney • Jan. 29, 2026

Has Novavax cracked the code for survival in the vaccine arena?

The company’s new partnership with Pfizer is worth up to $530 million — and could be just the beginning.

By Meagan Parrish • Jan. 28, 2026

Explore the 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

Biopharma layoffs surged last year, but 2026 is a chance to turn the page

Companies are adjusting to turbulence in the U.S. market, and more traditional job loss factors will likely be at play in the coming year.

By Kelly Bilodeau • Jan. 26, 2026

US drug pricing policies are ‘red lights’ for investors, and China beckons

Pricing policies like most-favored nation and the Inflation Reduction Act, as well as a destabilized FDA, are pushing investors to look outside the U.S.

By Michael Gibney • Jan. 22, 2026

Lilly, Takeda targeted by legal strategy usually reserved for the mob

A case targeting alleged fraud around the safety risk of a blockbuster diabetes drug is leveraging the RICO pathway and could have a ripple effect in pharma.

By Kelly Bilodeau • Jan. 20, 2026

Trump unveils healthcare affordability plan

The “Great Healthcare Plan” is vague, but would send money directly to ACA enrollees and entrench Trump’s drug pricing deals.

By Rebecca Pifer Parduhn • Jan. 16, 2026

Lilly, Novo test direct-to-employer approach that could cut out PBMs and lower costs

The GLP-1 giants are the first to try out this new model, but more companies may follow. 

By Kelly Bilodeau • Jan. 14, 2026

The wellness industry is HHS’ new belle of the ball

Congressional leaders and health experts are sounding the alarm about potential conflicts of interest among the agency’s new leaders.

By Kelly Bilodeau • Jan. 8, 2026

5 FDA drug approvals to watch in 2026

Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this year.

By Alexandra Pecci • Jan. 7, 2026

PharmaVoice’s Crystal Ball: Market and policy forces shaping the industry

How pharma leaders believe the regulatory and investment market landscape will change in 2026. 

By Meagan Parrish • Jan. 6, 2026

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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