Policy & Regulation
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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 -
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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 -
Explore the Trendline➔
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TrendlineEmerging 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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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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 -
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Lilly’s leap into psychedelics; peptides in the spotlight
Eli Lilly is extending its push in neuroscience while the FDA wrestles with controversial peptide drugs.
By PharmaVoice Staff • July 24, 2026 -
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What’s in the FDA’s latest batch of rejection letters
A look at two recent CRLs demonstrate the tension and discrepancies between how companies and the agency communicate drug rejections.
By Alexandra Pecci • July 23, 2026 -
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Why the FDA’s top spot could sit empty for months
Multiple factors could get in the way of confirming a new commissioner before the midterm elections, experts said, leaving the agency’s long-term initiatives in limbo.
By Susanna Vogel • July 22, 2026 -
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What policies could last — or could get axed — amid leadership churn at FDA
How new review policies, the use of AI and other recent FDA changes are being impacted by high turnover at the top.
By Kelly Bilodeau • July 10, 2026 -
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HHS plan to speed drug R&D won’t remove ‘self-inflicted’ delays
U.S. clinical trials continue to lose ground to China, but is Operation Trialblazer enough to help America catch up?
By Kelly Bilodeau • July 8, 2026 -
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HHS, responding to China’s rise, moves to fast-track early drug research
A series of newly planned reforms are designed to entice companies to start early trials in the U.S. rather than overseas.
By Jonathan Gardner • June 24, 2026 -
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As M&A rebounds, here’s how pharmas can prepare to seal a deal
Drugmakers that aren’t ready when financial opportunity knocks could get caught flat-footed in a competitive market.
By Kelly Bilodeau • June 18, 2026 -
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Amid a flurry of biotech deals, China looks to keep innovation at home
The country's new regulatory pathway promises to accelerate access to advanced therapies for Chinese patients, but may change the licensing game for foreign companies.
By Kelly Bilodeau • June 10, 2026
