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

J&J accelerates past Stelara’s fall with better-than-expected portfolio growth

Stelara is faltering due to biosimilar entries, but J&J execs demonstrate they were ready to fill the gap all along.

By Michael Gibney • July 17, 2025

Explore the Trendline➔

Oncology R&D

Cancer research remains a prime focus for the industry and often leads to pharma’s most impactful breakthroughs.   

By PharmaVoice staff

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

Need a DTC platform? Here’s how one company built its own.

Currax Pharmaceuticals was ahead of the curve when it set up a direct access platform for its obesity med. 

By Amy Baxter • July 14, 2025

With Verona deal, Merck wagers on strength of lung drug’s patents

The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make good on the deal, other secondary patents will need to hold up.

By Jonathan Gardner • July 11, 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

As its cancer vaccine moves through the clinic, Transgene sets sights on manufacturing

Simone Steiner recently joined the French company to set the stage for launch.  

By Amy Baxter • July 9, 2025

Is biopharma dealmaking getting hot again?

With pharma’s finger on the M&A button, three of the biggest deals of the year are breadcrumbs that could lead to a full-on resurgence.

By Michael Gibney • July 8, 2025

The MEK effect on cancer — a slow and steady approach to drug resistance

Immuneering Corporation’s investigational MEK inhibitor aims to outpace cancer while reducing resistance and side effects.

By Kelly Bilodeau • July 8, 2025

GLP-1 roadblocks: Discontinuation rates soar as insurers clamp down

As more drugmakers aim for the lucrative weight loss market, patient challenges linger.

By Amy Baxter • July 7, 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

AI’s ‘massive transition’ in biopharma shapes leadership mindsets — tension and all

The AI revolution is driving tension between new technology and the traditional approaches in drugmaking. Biopharma leaders are trying to navigate those turbulent waters.

By Michael Gibney • July 1, 2025

A biopharma bolsters patient centricity and trial diversity goals through newly created role

Ardelyx’s newly minted chief patient officer is infusing patient experiences into every element of the business.

By Alexandra Pecci • July 1, 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

Biopharma is on edge about NIH funding cuts and what the future holds for research

Proposed cuts to public funding for early science have led to an outcry in scientific circles. For biopharma leaders, the effects are still up in the air.

By Michael Gibney • June 26, 2025

After myriad failures, a new wave of ALS drugs approaches

Several drugmakers anticipate trial results and FDA submissions in 2025 and 2026, including some still overcoming past failures.

By Amy Baxter • June 25, 2025

Biogen scores Cannes Festival win with dark humored campaign

The company’s unique campaign for a rare, terminal illness nabbed millions of views and a spot on the main stage at the Cannes Lions Festival of Creativity.

By Alexandra Pecci • June 24, 2025

Megablockbusters are the holy grail. Here’s how drugmakers are getting there.

More drugs surpassed $10 billion in revenue last year than ever before.

By Amy Baxter • June 23, 2025

Is DTC pharma advertising coming to an end?

A bill introduced in Congress fulfills a Trump administration goal of ending direct pharma ads to patients.

By Amy Baxter • June 18, 2025

FDA to speed reviews for drugs supporting ‘national interests’

A new pilot program announced by FDA Commissioner Dr. Martin Makary would award vouchers that could cut drug reviews to one or two months — but only for products that meet a special criteria.

By Jonathan Gardner • June 18, 2025

How a patient group tackled research diversity for one disease and triggered change for pharma

A policy win by the Foundation for Sarcoidosis Research has built momentum for other shifts that could bolster diversity in clinical trials.

By Meagan Parrish • June 17, 2025

Locked in a federal stalemate, states take PBM reform into their own hands

Arkansas is leading the nation in banning PBMs from owning pharmacies, as other states advance new restrictions.

By Amy Baxter • June 16, 2025