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

Explore the Trendline➔

Emerging biotech

After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

By PharmaVoice staff

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

AI regulation lags despite entering higher-risk patient care

While more pharma companies launch DTC platforms, states, not the federal government, are providing guardrails to protect patient privacy and safety.

By Kelly Bilodeau • Feb. 2, 2026

Pharma’s outlook in 2026: Smoother sailing ahead?

After a turbulent year, the industry has a clearer picture of its new landscape and how to navigate the challenges and opportunities ahead. 

By Meagan Parrish • Jan. 30, 2026

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

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