As biosimilars gain US traction, patent thickets are under more scrutiny

A 10-year push for more biosimilars in the U.S. has led to a surge in copycat entrants, bringing more attention to the legal barriers.

By Michael Gibney • April 28, 2026

FDA’s need for speed could strain small biotechs. Here’s how they can keep up.

In a more politically charged environment, getting drugs across the finish line is increasingly complex and uncertain.

By Kelly Bilodeau • April 27, 2026

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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

HHS, industry leaders spar over drug pricing, TrumpRx and PBMs

Debate about drug costs erupted among prominent healthcare figures, including Dr. Oz, Mark Cuban, Calley Means and PhRMA in Washington, D.C., but they all agreed on one thing: The system is broken.

By Michael Gibney • April 23, 2026

Who is Dr. Houman Hemmati, potentially CBER’s next leader?

Where the rumored frontrunner stands on key issues like vaccines and public health policy.

By Kelly Bilodeau • April 20, 2026

5 notable pharma CEO pay hikes in 2025

Several of pharma’s top leaders scored large pay bumps last year, including two new chiefs who joined the “$30 million club.”

By Alexandra Pecci • April 14, 2026

Will RFK Jr.’s peptide push bolster the gray market for obesity drugs?

With competition fierce in the weight loss space, a potential change to how the FDA classifies peptides could increase pressure in the market even more.

By Alivia Kaylor • April 10, 2026

Tariffs are back. What does it mean now for pharma?

While the Trump administration has again levied large new tariffs, drugmakers willing to make deals could gain some relief.

By Kelly Bilodeau • April 6, 2026

How Trump’s war in Iran is scrambling pharma’s shipping options

A blockade at one of the world’s largest shipping lanes could shape the way pharma companies think about manufacturing and distribution.

By Michael Gibney • April 2, 2026

mRNA is poised to rise beyond infectious diseases, if it’s not derailed by R&D cuts

Research into areas like cancer could become collateral damage of a broader anti-mRNA push, according to a new study.

By Alexandra Pecci • March 31, 2026

The FDA’s shame game

The agency is becoming more open about its criticisms of pharma companies and leaders, raising new privacy concerns in the industry.

By Kelly Bilodeau • March 30, 2026

Mixed signals cloud the orphan drug market

The field is making gains despite regulatory inconsistency, but rising competition from obesity candidates and evolving global pressures could erode orphan drugs’ market share.

By Kelly Bilodeau • March 25, 2026

Gilead could potentially end HIV. But will it be able to?

After launching a PrEP medication that was 100% effective in clinical trials, the company is facing a complex global rollout and leveraging its network of partners for help.

By Meagan Parrish • March 20, 2026

Federal court blocks RFK Jr.’s moves to upend US vaccine policy

HHS ignored established protocols in altering the childhood immunization schedule and overhauling a CDC panel, according to the ruling.

By Delilah Alvarado • March 17, 2026

What’s at stake for Bayer in its Supreme Court showdown?

A key case being heard by the Supreme Court could help the large pharma put its Roundup litigation to rest.

By Kelly Bilodeau • March 16, 2026

Keytruda’s reign continues; pharma’s megadeal drought

Merck & Co.’s landmark cancer drug is still the industry’s bestseller despite the rise of GLP-1s — and other topics on our radar this week.

By PharmaVoice Staff • March 13, 2026

New FDA guidance could elevate pharma’s biosimilar market

Biologic copycats are making a bigger impact on drug prices as U.S. regulators open the doors wider, and new guidance could improve their standing even more.

By Michael Gibney • March 12, 2026

Executives want in, but researchers want out — how pharma’s US job picture is changing

While academics are eyeing friendlier work opportunities abroad, America’s manufacturing boom is drawing industry leaders to its shores.

By Alexandra Pecci • March 10, 2026

What 3 recent FDA rejections reveal about shifts inside the agency

The FDA’s approval strategy has been difficult to pin down, but recent decisions provide clues for how some of the most volatile initiatives will play out.

By Alexandra Pecci • March 4, 2026

How PBM reforms could push drugmakers into the pricing spotlight

The Consolidated Appropriations Act's landmark PBM overhaul removes financial incentives tied to pharma list prices, potentially leaving drugmakers to defend their own practices.

By Alivia Kaylor • Feb. 27, 2026

Biohaven says FDA roadblocks leave rare disease patients in limbo

An FDA rejection last year for a rare disease drug from Biohaven reflects the amount of work left to get patients the treatments they need, the company says.

By Michael Gibney • Feb. 26, 2026

Will the FDA yank mRNA vaccines?

Adding increased obstacles and sowing safety doubts may be enough to chill mRNA vaccine use and development.

By Alexandra Pecci • Feb. 24, 2026

How does the FDA really feel about psychedelics? We could soon find out.

Compass Pathways’ psilocybin-based drug is edging closer to an approval but faces mixed signals from officials.

By Kelly Bilodeau • Feb. 23, 2026

Will vaccine regulatory uncertainty chill innovation? Pharma execs sound off.

Moderna’s clash with U.S. health agencies over its flu shot reflects a difficult time for vaccinemakers, but many are still playing the waiting game.

By Michael Gibney • Feb. 19, 2026

New FDA guidance that’s a ‘huge deal’ for clinical trials

Why using Bayesian statistics could transform trial design for rare diseases and beyond.

By Kelly Bilodeau • Feb. 10, 2026

Why TrumpRx is stumbling before it gets off the ground

Concerns about potential kickbacks, costs and conflicts have triggered calls for oversight.

By Kelly Bilodeau • Feb. 4, 2026