FDA approves updated COVID boosters, but narrows use

In a post on X, HHS Secretary Robert F. Kennedy said the FDA has cleared vaccines from Pfizer, Moderna and Novavax for use in "high risk" individuals.

By Delilah Alvarado • Updated Aug. 27, 2025

Why an FDA decision for a new drug could ripple through the ultra-rare disease space

All eyes are on Stealth BioTherapeutics as it awaits a long-delayed approval for its first-in-class treatment for Barth syndrome.

By Alexandra Pecci • Aug. 26, 2025

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

FDA’s new accelerated pathway could open pharma up to risks, as well as benefits

Faster review times will leave drugmakers vulnerable to litigation, while new Trump administration priorities add more uncertainty in the drug approval process.

By Amy Baxter • Aug. 25, 2025

MAHA leaders may take aim at pharma DTC advertising

RFK Jr. has his sights set on increasing advertising enforcement against pharmas, but may not come down as hard on the industry as previously thought.

By Amy Baxter • Aug. 20, 2025

Despite FDA ruling, compounded GLP-1s are still giving Novo and Lilly headaches on the market

Copycat weight loss drugs were supposed to be pulled from the market, but pharmacies have found a loophole. 

By Amy Baxter • Aug. 18, 2025

With scrapped mRNA funding, a vaccine maker finds a silver lining

While mRNA is suffering the brunt of the MAHA movement with $500 million in funding cuts, other vaccine makers could fill some of that void.

By Michael Gibney • Aug. 14, 2025

With FDA PreCheck, drugmakers may get a manufacturing boost

The newly announced program targeting domestic manufacturing is the latest Trump administration move to ramp up drugmaking in the U.S.

By Amy Baxter • Aug. 13, 2025

Puerto Rico’s ongoing journey from manufacturing hub to innovation enterprise

Biotechs are coming to the island as tariffs threaten overseas drug exports, and finding Puerto Rico is more than just a leading manufacturing hub.  

By Michael Gibney • Aug. 12, 2025

Are stem cell therapies ready for pharma’s prime time?

Stem cell therapies are thriving on the fringes of healthcare — but science-backed treatments are also poised to make an impact in pharma R&D.

By Kelly Bilodeau • Aug. 11, 2025

As gene therapies falter on the market, this biopharma is aiming to defy the odds

After a strong launch for its cancer gene therapy, Ferring Pharmaceuticals is setting the stage for long-term growth.

By Meagan Parrish • Aug. 8, 2025

PBM reform was dropped from Trump’s spending bill. It could have saved billions.

The Senate nixed a provision to “delink” drug list prices from compensation for PBMs and other drug middlemen days before its passage.

By Alexandra Pecci • Aug. 6, 2025

Drugmakers score policy win in a prolonged fight against 340B

A new pilot program from HHS would alter the contentious 340B pricing program by swapping traditional upfront drug discounts for rebates.

By Amy Baxter • Aug. 4, 2025

Dr. Vinay Prasad, controversial FDA official, abruptly departs agency

Prasad's exit ends a tumultuous tenure during which he led a reworking of agency guidelines on COVID vaccines and his office got embroiled in controversy over a Duchenne gene therapy.

By Ben Fidler • July 30, 2025

From the bench: Researchers make NIH-funded preclinical strides in mRNA and obesity

The studies are contributing preclinical advances for some of the world’s biggest blockbusters.

By Michael Gibney • July 25, 2025

Who is Dr. George Tidmarsh, the new director of CDER?

Despite past criticism of public health policies, Tidmarsh recently praised the FDA and said he’ll focus on boosting review efficiencies.

By Meagan Parrish and Michael Gibney • July 23, 2025

Novartis’ Zolgensma sales fall again as gene therapy market woes persist

Novartis has seen sales decline in a difficult gene therapy market. Is there hope on the horizon?

By Michael Gibney • July 22, 2025

Why FDA’s CRL release could open the door to lawsuits against pharma

In a push for “radical transparency” the FDA released 200 CRLs for drugs that were later approved — some of which are now public for the first time.

By Meagan Parrish • July 18, 2025

FDA invites more data from abroad — with a wary eye on China

The FDA approved four drugs last year without any U.S. trial participants, but has maintained a tougher stance on China, even as it grows into an R&D powerhouse.

By Amy Baxter • July 16, 2025

Biotech IPO momentum gained steam last year, but market ‘turmoil’ has slowed the train again

The IPO market is a mixed bag in 2025, with some signs of life but several headwinds keeping activity relatively low.

By Michael Gibney • July 15, 2025

Pricing watchdog will take on the rising cost of drugs at launch

ICER’s upcoming report could shed light on how the launch price of newly approved drugs affects overall cost and access from a patient perspective.

By Michael Gibney • July 10, 2025

Trump says ‘very high’ pharmaceutical tariffs coming soon

While Trump indicated drug levies would be as high as 200%, he added that pharma firms would first be given time to bring manufacturing back to the U.S.

By Philip Neuffer • July 9, 2025

Can China sustain a surge in oncology drug innovation?

The country’s trajectory may get a boost from anticipated results of a Keytruda rival’s U.S. trials.

By Kelly Bilodeau • July 2, 2025

FDA’s new mission to speed drug reviews

FDA Commissioner Dr. Marty Makary is leading a handful of controversial new initiatives to make the drug review process more streamlined.

By Amy Baxter • June 30, 2025

3 of the year’s most notable FDA nods

The agency has granted approvals steadily in the first part of the year, including nods for several breakthrough therapies.

By Meagan Parrish • June 27, 2025

CDC panel, newly remade by RFK Jr., questions vaccine evidence

New members of the ACIP panel raised questions about the evidence supporting COVID vaccines, and signaled plans to look at other established shots, like those for measles and hepatitis B.

By Delilah Alvarado • June 26, 2025