Policy & Regulation
-
Mario Tama / Getty via Getty Images
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 -
Alex Wong via Getty Images
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 -
Explore the Trendline➔
Stock via Getty Images
TrendlineRare diseases
As drug developers find promise in the rare diseases, deals and treatments are on the rise
By PharmaVoice staff -
Anna Moneymaker via Getty Images
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 -
Stock via Getty Images
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 -
Stock via Getty Images
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 -
Stock via Getty Images
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 -
Andrew Harnik via Getty Images
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 -
stock via Getty Images
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 -
Retrieved from Vinay Prasad on May 08, 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 -
E+ via Getty Images
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 -
Mario Guti via Getty Images
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 -
Sedat Suna via Getty Images
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 -
Stock via Getty Images
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 -
Stock via Getty Images
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 -
Michael M. Santiago via Getty Images
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 -
Getty Images via Getty Images
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 -
Andrew Harnik via Getty Images
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 -
E+ via Getty Images
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 -
Andrew Harnik via Getty Images
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 -
Justin Sullivan via Getty Images
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 -
Elijah Nouvelage via Getty Images
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 -
Grandbrothers via Getty Images
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 -
stock via Getty Images
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 -
Kayla Bartkowski via Getty Images
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 -
Stock via Getty Images
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
