FDA, aiming to lower drug costs, moves to speed approval of biosimilars

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help developers bring them to market more quickly and cheaply. 

By Jonathan Gardner • Oct. 29, 2025

Lilly aligns with Walmart in bid to broaden access to discounted Zepbound

The deal, which enables patients to pick up orders placed through Lilly’s online channel at Walmart pharmacies, is the latest move by the company to expand its direct-to-consumer services. 

By Jonathan Gardner • Oct. 29, 2025

Explore the Trendline➔

Commercialization

New drugs for obesity and Alzheimer’s look set to become blockbusters, reshaping pharma marketing strategies just as many current top-sellers near looming patent cliffs.

By BioPharma Dive staff

Iambic partners with Jazz; Merck breaks ground on $3B plant

The biotechs will assess a combination of two drugs against HER2-positive breast cancer. Elsewhere, Merck unveiled the latest piece of its more than $70 billion domestic manufacturing investment.

By BioPharma Dive staff • Oct. 21, 2025

Novo’s main shareholder pushes out more than half of company’s board

The Novo Foundation chair said the current board of the Wegovy maker, which is already dealing with layoffs and a CEO change, was too slow to react to obesity market shifts.

By Jonathan Gardner • Oct. 21, 2025

Mark Cuban says Cost Plus Drugs will partner with TrumpRx

Cost Plus Drugs is sharing pricing data with TrumpRx, the administration’s new direct-to-consumer prescription drug website set to launch next year.

By Susanna Vogel • Oct. 20, 2025

J&J claims success in study testing earlier Tecvayli use in multiple myeloma

The result marks a potential advance for dual-targeting antibody drugs like Tecvayli, which are currently relegated to later-line settings for the persistent blood cancer.

By Jonathan Gardner • Oct. 16, 2025

AI could transform healthcare. Can safety-net providers keep up?

Implementing artificial intelligence requires significant human labor and technical expertise, threatening to create a digital divide between highly resourced health systems and safety-net providers.

By Emily Olsen • Oct. 3, 2025

Amgen claims ‘landmark’ study result that could widen heart drug’s use

In a first-of-its-kind finding, Amgen’s PCSK9 drug protected heart health when tested as a “primary prevention” therapy, which could pave the way for access to a much broader population. 

By Jonathan Gardner • Oct. 2, 2025

Key exemptions could limit impact of Trump’s pharmaceutical tariffs

Carve-outs for generics, European exports and companies onshoring drug production will likely shield most branded drugs from the 100% levies Trump announced Thursday.

By Jonathan Gardner • Sept. 26, 2025

Disparity in vaccine access between states roils patients, providers

Recent changes to federal guidance on COVID vaccinations have providers worried about what’s to come. “We have opened a door to not using science to guide care,” one physician said.

By Susanna Vogel • Sept. 23, 2025

CDC panel, recast by RFK Jr., softens COVID vaccine recommendations

After a tumultuous two-day meeting marked by confusion and missteps, an advisory committee endorsed guidelines that would urge people to discuss vaccination's benefits and risks with their physician.

By Delilah Alvarado , Jonathan Gardner • Sept. 19, 2025

CDC advisers postpone vote to delay some newborns’ hepatitis B shot

Members of ACIP voted to table a planned vote on withholding some infants’ first hepatitis B vaccine dose, adding more confusion to an already muddied meeting.

By Delilah Alvarado • Sept. 19, 2025

Fired CDC director says RFK Jr. aims to change childhood vaccine schedule

Susan Monarez told Senators at a hearing Wednesday that Robert F. Kennedy Jr. pushed her out for refusing to rubber-stamp changes.

By Delilah Alvarado • Sept. 17, 2025

A key CDC panel meets today to discuss vaccines. Here’s what to know.

The remade ACIP panel is set to vote today on recommendations for use of vaccines for measles and hepatitis B. They’ll meet again tomorrow to discuss COVID shots.

By Delilah Alvarado • Updated Sept. 15, 2025

FDA clears J&J’s drug-device combo for bladder cancer

J&J executives have said they expect the therapy, Inlexzo, to become a future blockbuster and generate sales that significantly outstrip Wall Street forecasts.

By Jonathan Gardner • Sept. 10, 2025

At Senate hearing, lawmakers express dissatisfaction with RFK Jr.’s vaccine moves

Robert F. Kennedy Jr. faced criticism Thursday even from Republicans over changes to federal vaccine policy as well as a leadership crisis at the CDC.

By Delilah Alvarado , Jonathan Gardner • Sept. 4, 2025

Biohaven’s rare disease drug is ‘ready to ship on Day 1’ following FDA approval

CEO Vlad Coric said the company has a patient hub, payer managers and a small sales force set up to ensure a successful launch of Vyglxia, a brain medicine that could be approved this year.

By Jacob Bell • Updated Sept. 4, 2025

Ionis looks to expand use of lipid-lowering drug after trial hits goal

Tryngolza, the first wholly owned drug Ionis has launched, helped people with high triglyceride levels that aren’t genetically driven.

By Jonathan Gardner • Sept. 2, 2025

CDC panel to discuss COVID, hepatitis B shots in meeting next month

A federal register notice confirmed dates for the anticipated advisory meeting, which will follow an FDA decision to narrow COVID boosters' approval and comes as CDC leadership is in turmoil.

By Delilah Alvarado • Aug. 28, 2025

MAHA may take aim at pharma DTC ads

RFK Jr. has his sights set on increasing oversight and enforcement against drugmakers that run afoul of advertising laws.

By Amy Baxter • Aug. 20, 2025

HHS revives defunct task force on childhood vaccine safety

The panel’s reinstatement is one of a series of controversial moves made by Robert F. Kennedy Jr. to put vaccines under new scrutiny.

By Delilah Alvarado • Aug. 15, 2025

BioNTech ends patent fight with mRNA rival CureVac ahead of buyout deal

The complex settlement, which hands payouts and royalties to CureVac and partner GSK, comes as BioNTech is inching toward an acquisition of its one-time COVID-19 vaccine competitor.

By Jonathan Gardner • Aug. 8, 2025

Novo pushes back against obesity drug compounders as competition intensifies

The company hopes an important CVS deal and broader legal action against the makers of knockoff Wegovy can solidify its slipping position in the lucrative market for weight loss drugs.

By Jonathan Gardner • Aug. 6, 2025

Experts ousted from CDC panel warn of damage to US vaccine policy

The 17 advisers fired in June by Robert F. Kennedy Jr. urged alternatives to ACIP be organized to limit further degradation in vaccine guidelines.

By Delilah Alvarado • July 31, 2025

Alnylam reaches new highs on strong sales of closely watched rare disease drug

Despite battling drugs from BridgeBio and Pfizer, Amvuttra beat Wall Street expectations with results Alnylam’s CEO claimed were “not a flash in the pan.”

By Ben Fidler • July 31, 2025