Pierre Fabre seeks to revive US approval chances for spurned cell therapy

Ebvallo is one of a series of rare disease treatments recently turned back by the FDA amid shifting guidance that has surprised some companies and frustrated investors.

By Jonathan Gardner • March 3, 2026

Roche pill succeeds in another MS study, but approval questions linger

Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared Phase 3 studies in multiple forms of the disease.

By Jonathan Gardner • March 2, 2026

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Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

Lilly’s GLP-1 pill tops Novo’s Rybelsus in head-to-head trial

Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but at the expense of higher side effect rates. 

By Jonathan Gardner • Feb. 26, 2026

Bristol Myers says ADC licensed from China hits mark in aggressive breast cancer

The study result is the latest step forward for a drug Bristol could eventually pay more than $8 billion for and has spotlighted as important to its future growth.

By Kristin Jensen • Feb. 26, 2026

GSK to acquire 35Pharma in $950M deal for cardiovascular drug

The deal hands GSK a drug it views as a potentially “best-in-class” therapy for blood pressure diseases like pulmonary arterial hypertension — the target of Merck’s fast-selling Winrevair.

By Kristin Jensen • Feb. 25, 2026

With Vivtex deal, Novo gains a chance at better oral obesity drugs

The potentially $2.1 billion collaboration gives Novo access to technologies that are meant to help optimize the delivery of oral biologic medicines. 

By Gwendolyn Wu • Feb. 25, 2026

Novo’s next-gen obesity shot fails to match Lilly drug in head-to-head study

Shares fell by more than 15% on results showing study participants receiving Novo’s CagriSema lost less weight than those who took Lilly’s Zepbound.

By Jonathan Gardner • Feb. 23, 2026

Merck to split cancer, specialty drug businesses in leadership shakeup

Ahead of the looming loss of Keytruda’s exclusivity, the company is creating a standalone, cancer-focused unit and a second business housing its other drugs and vaccines.

By Ben Fidler • Feb. 23, 2026

Small and mighty: single-domain antibodies pack a biological punch

VHH antibodies: they’re not just small, they're modular engineering platforms, capable of powerful biological activity. But with great power comes great challenges!

By Jingyuan Zhang • Feb. 23, 2026

Supreme Court invalidates Trump tariffs based on emergency powers

In a 6-3 decision, the court rejected President Trump's claim that a 1977 law gave him the authority to impose broad tariffs globally.

By Antone Gonsalves • Feb. 20, 2026

Trump sets fresh 10% global tariff — and plans to increase further

The new duties will go into effect Feb. 24, although the president has since signaled he will raise the rate to 15%.

By Antone Gonsalves , Phil Neuffer • Updated Feb. 21, 2026

Roche gets FDA decision date on closely watched breast cancer drug

The agency could by late December approve a therapy that Roche sees as potentially becoming a new treatment standard for certain breast tumors. 

By Jonathan Gardner • Feb. 20, 2026

AI is slashing jobs across industries. Will pharma be next?

Despite a wave of AI-fueled layoffs, the pharma and biotech industries could be spared from massive cutbacks for now.

By Alexandra Pecci • Feb. 20, 2026

Lilly to pay CSL $100M to license monoclonal antibody targeting IL-6

The Australian company will retain rights for an end-stage kidney disease indication currently being tested in a Phase 3 trial while Lilly explores other uses.

By Kristin Jensen • Feb. 18, 2026

FDA accepts BMS protein degrader for review; Disc rare disease drug rejected

Cytokinetics’ heart disease drug secured European approval. Elsewhere, Teva and Sanofi reported longer-term data from an experimental therapy targeting ulcerative colitis and Crohn’s disease.

By BioPharma Dive staff • Feb. 18, 2026

How to evaluate prospective diagnostic laboratory partners for your patient support program

As specialty medicines account for an increasing share of the drug pipeline, it makes sense for sponsors to support patients financially, emotionally and logistically.

Feb. 17, 2026

Sanofi, looking for more ‘rigor,’ swaps CEO Hudson for ex-Merck KGaA chief Garijo

The move drew skepticism from investors despite multiple recent research setbacks that have left questions about Sanofi’s ability to confront Dupixent’s looming patent expiration.

By Kristin Jensen • Feb. 12, 2026

Takeda, Iambic partner in latest pharma AI push

“The winners over the next five years” will be the companies that “fully integrate” artificial intelligence into drug development, said Takeda research chief Andy Plump.

By Jacob Bell • Feb. 9, 2026

Hims cancels plans to sell compounded GLP-1 pill after FDA backlash

Hims said it “deciding to stop offering access” to the treatment following escalating legal threats — among them a patent infringement suit Novo Nordisk filed against the company on Monday.

By Ben Fidler • Updated Feb. 9, 2026

White House’s online service for drug sales debuts with limited impact on prices

Select products from Pfizer, Eli Lilly and others will be sold at a discount, although the lower costs won’t be felt by many Americans whose medications are covered by insurance.

By Jonathan Gardner • Feb. 6, 2026

Earnings roundup: AbbVie angst, a bifurcated vaccine market and Bristol Myers’ waiting game

Vaccine makers are seeing sales declines in the U.S. and upswings in Europe. Elsewhere, investors fretted over an AbbVie franchise and Bristol Myers pointed to a trio of narrative-changing trials.

By BioPharma Dive staff • Feb. 5, 2026

Novo, Lilly sputter as Hims launches knockoff GLP-1 pill

Novo is threatening litigation in response, while FDA head Martin Makary, without naming specific companies, said the agency would take “swift action” against those “mass-marketing illegal copycat drugs.”  

By Ben Fidler • Updated Feb. 6, 2026

Bayer details anticipated stroke prevention data for new blood-thinner

Asundexian cut the risk of an additional stroke by 26% in a large Phase 3 trial without accompanying safety issues, boosting the commercial outlook for an emerging class of anti-clotting drugs.

By Jonathan Gardner • Feb. 5, 2026

Novo shares tumble by double digits on grim sales outlook

In contrast to Lilly’s optimistic forecasts, Novo cited pricing constraints and competitive pressure in predicting up to a 13% decline in 2026 profits. 

By Jonathan Gardner • Feb. 4, 2026

Lilly soars again as fast-selling weight loss drugs top Wall Street projections

Despite some angst over pricing pressure for GLP-1 drugs, Lilly’s bullish projections surpassed consensus estimates, while combined 2025 sales of Zepbound and Mounjaro eclipsed $36 billion.

By Kristin Jensen • Feb. 4, 2026