FDA ‘reset’ continues with new plan for reviewing rare disease drugs

A revamped regulatory framework may give investors less of a “guessing game” as they weigh chances for drug approvals, one analyst said.

By Kristin Jensen • Oct. 16, 2026

Lilly is fighting a black market for its new obesity drug even before it launches

The large pharma’s promising new candidate retatrutide is still in the clinic. But Lilly is already fighting a web of illicit sellers for the drug online.

By Kelly Bilodeau • Oct. 12, 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

HHS’ need for R&D speed; weird GLP-1 side effects

HHS is cranking up its efforts to accelerate drug development; more reports are emerging about off target effects of obesity drugs. 

By PharmaVoice Staff • Oct. 9, 2026

5 key facts about the FDA expedited IND pilot program

The program, part of Operation TrialBlazer, aims to speed early research and help the U.S. bring trials back from overseas.

By Kelly Bilodeau • Oct. 7, 2026

Top pharma industry conferences in 2027

Where pharma and biotech leaders will converge to network, share ideas and potentially strike deals.

By Meagan Parrish • Oct. 6, 2026

Basecamp raises $140M before the clinic; J&J and Compass’ potential rivalry

Some of the biggest news and trends captured in PharmaVoice’s newsletter this week. Sign up here to receive the newsletter daily. Another big AI haul Investors are still lining up to back AI drug developers before their candidates reach human trials. Basecamp Research...

By PharmaVoice Staff • Sept. 25, 2026

Where does FDA nominee Overton stand on vaccines and other key pharma issues?

Pressed by lawmakers on Thursday, Trump’s pick as the next FDA chief said she’d “follow the law” on vaccine-related decisions and work to speed early drug R&D.

By Jonathan Gardner • Sept. 24, 2026

A hidden tradeoff in Trump’s MFN drug deals

The government has announced pricing agreements with 26 pharma companies. But the deals could stymie other plans to lower the country’s drug spend.

By Kelly Bilodeau • Sept. 21, 2026

Where female participation in clinical trials has caught up — and where gaps remain

Getting more women into drug R&D remains critical for boosting health outcomes. But in some disease areas, pharma is still falling behind.

By Kelly Bilodeau • Sept. 16, 2026

PDUFA reauthorization offers a chance at clinical trial reforms. Will the US take it?

The reauthorization could give Congress the opportunity to help streamline clinical trials and accelerate drug research.

By Kelly Bilodeau • Sept. 14, 2026

FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders

After almost two years of turnover in the FDA’s top ranks, the new appointments should help ease concerns about more turmoil ahead, one analyst said. 

By Kristin Jensen • Sept. 9, 2026

Prediction markets are putting a price on pharma’s secrets. Here’s what companies need to know.

As betting expands into clinical trial outcomes, drugmakers may need to look beyond employees and scrutinize outside partners with access to sensitive information.

By Sy Mukherjee • Sept. 8, 2026

Gilead’s growing HIV franchise; cell therapy licensing deals plummet

The FDA recently OK'd Gilead's novel HIV combo med, and cell therapy deals have fallen dramatically in two years.

By PharmaVoice Staff • Sept. 4, 2026

As measles outbreaks soar, where does drug R&D stand?

More than 25 years after it was declared eliminated, measles has surged back. But drug R&D is still in early stages and up against a tense market environment.

By Alexandra Pecci • Sept. 4, 2026

Autoimmune CAR-T faces tough questions after Novartis, Bristol Myers study halts

Wall Street analysts believe that a more cautious approach to manufacturing, study enrollment and side effect management could help developers avoid future safety hazards.

By Jonathan Gardner • Sept. 3, 2026

China’s clinical trial boom under scrutiny after 3 deaths come to light

Two House Republicans are asking the FDA to increase oversight of China-generated clinical data after three trial deaths are reported.

By Kelly Bilodeau • Sept. 3, 2026

Trump signs order seeking to upend childhood vaccine schedule

The executive order — which wasn’t accompanied by any new scientific evidence — aims to split the MMR vaccine into three separate shots and revives the administration’s attempt to slim down the immunization schedule.

By Delilah Alvarado • Aug. 11, 2026

Large pharmas skirt tariffs; BMS’ dealmaking drought

Big Pharmas won't get hit new levies on branded drugs; and aside from the megamerger rumors, BMS has had a relatively quiet year for M&A.

By PharmaVoice Staff • Aug. 7, 2026

Erica Schwartz confirmed as next CDC director

Schwartz will step into an agency that has been without a permanent leader for almost a year amid RFK Jr.’s tumultuous tenure as HHS chief. 

By Kristin Jensen • Aug. 6, 2026

What the AstraZeneca-BMS rumors reveal about pharma megamergers

Reports of talks were quickly disputed, but the prospect exposed the appeal — and antitrust risks — of combining two pharma giants.

By Kelly Bilodeau • Aug. 6, 2026

FDA allows unique endpoint in rare disease study

Global regulators are allowing the company to use hospitalization as the primary efficacy endpoint in its registration trial for a rare neuromuscular disorder.

By Alexandra Pecci • Aug. 5, 2026

Trump has another tariff plan to reshore generic drug production. Will it work?

The president’s most recent tariff proposal gives pharma more time to transition its global supply chain and reshore generic drug production.

By Kelly Bilodeau • Aug. 3, 2026

Genetic clues for cell therapy toxicities; Summit’s high-stakes FDA decision

Researchers have pinpointed genes linked to dangerous CAR-T cell therapy side effects, and a predictions market weighs in on Summit’s closely-watched cancer drug.

By PharmaVoice Staff • July 31, 2026

Kalshi is expanding online betting in drug R&D — unless detractors can stop it

Kalshi sees drug development predictions as a way to improve R&D transparency. Critics say they could create financial incentives around research and undermine public trust.

By Susanna Vogel • July 28, 2026

The FDA was all in on AI. Will that change?

High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.

By Kelly Bilodeau • July 24, 2026