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

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

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

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

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

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

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

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

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

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

BMS under pressure in schizophrenia; Summit/Akeso on a winning streak

While the large pharma’s new drug Cobenfy has stumbled in schizophrenia, it could find new life in Alzheimer’s disease

By PharmaVoice staff • June 5, 2026

House bill aims to crack down on China biotech deals

A proposal to add biotechnology to the COINS Act follows two big deals involving Pfizer and Bristol Myers, and comes amid U.S. fears that China’s drugmaking progress may threaten national security.

By Kristin Jensen • June 4, 2026

When the ISS comes down, will its drug R&D be lost in space?

 As NASA prepares to bring its hallmark space lab back to Earth, a host of private companies are emerging to fill the gap.

By Meagan Parrish • June 3, 2026

Can AI crack pharma’s drug repurposing goldmine?

With AI now capable of analyzing decades’ worth of data, FDA is pushing pharma to leverage its “enormous, untapped value” by repurposing drugs.

By Alivia Kaylor • May 29, 2026

Can a chaotic FDA still deliver on faster drug development?

As leadership changes create more instability at the agency, here's what it'll take to keep speedier drug approvals on track. 

By Kelly Bilodeau • May 26, 2026

China’s biotech rise sparks new US industry alliance

The nonprofit is aiming to inspire a new moonshot effort that helps the U.S. maintain its position as a drug innovation leader.

By Kelly Bilodeau • May 21, 2026

Sanofi’s vaccine bump; the new FDA commish

A look at how vaccine makers are scraping by, and at the incoming acting FDA head, Kyle Diamantas.

By PharmaVoice staff • May 15, 2026

Former Ovid CEO Dr. Jeremy Levin’s rallying cry for biotech

The long-time pharma exec is on a quest with a new book and bold message for biotech leaders and U.S. lawmakers.

By Meagan Parrish • May 15, 2026

FDA chief’s exit clouds already murky drug approvals

During Dr. Martin Makary’s tenure as commissioner, the FDA faced pushback over high-profile drug rejections for Replimune and UniQure.

By Kelly Bilodeau • May 14, 2026

India’s pharma industry is going global. But can it catch up to China?

A record  Sun Pharma acquisition signals global ambitions. But infrastructure, capital and policy gaps could stand in the way of India becoming an R&D powerhouse.

By Kelly Bilodeau • May 13, 2026

Why the FDA’s push for real-time clinical trials could favor Big Pharma

The agency's new initiative promises faster drug approval times, but smaller trial sponsors could struggle to keep up.

By Alivia Kaylor • May 13, 2026

How tough is it getting for vaccine makers in the U.S.?

As federal policy chills domestic demand, some companies are increasingly leaning on sales from international markets.

By Kelly Bilodeau • May 12, 2026

A new company rises from the ashes of Purdue Pharma

Knoa Pharma will still sell the opioid medications that triggered a national crisis, but with guardrails.

By Kelly Bilodeau • May 6, 2026

What’s at stake in Amgen’s showdown with the FDA?

The agency accused Amgen of manipulating data for its fast-growing drug Tavneos and wants it pulled from the market, but the large pharma is digging its heels in.

By Meagan Parrish • May 5, 2026

Protein degraders gain speed as Arvinas scores landmark approval

Although excitement over the biotech’s “Protac” protein degrader is being tempered by narrower-than-expected clinical benefit, R&D in the field is heating up.

By Kelly Bilodeau • May 4, 2026

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