Merck ADC, licensed from China, hits mark in first big global trial

The endometrial cancer trial is the first of 17 late-stage studies Merck is running for a therapy that’s important to its ambitions of hitting $70 billion in annual sales next decade.

By Jonathan Gardner • May 18, 2026

Regeneron immunotherapy combo comes up short in melanoma trial

A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in market value.

By Ben Fidler • May 18, 2026

Explore the Trendline➔

Oncology's research boom

More than one quarter of the medcines cleared by the FDA's main review office since 2015 have been cancer drugs, a tally that reflects the advent of cancer immunotherapy as well as continued progress in matching treatment to genetics.

By BioPharma Dive staff

FDA hold puts Aardvark Prader-Willi drug in limbo

The company plans to unblind the late-stage study that was halted due to safety concerns, which could lead to an overhaul of its entire development program.

By Jonathan Gardner • May 15, 2026

Biogen pushing tau drug forward despite Alzheimer’s study failure

One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.

By Kristin Jensen • May 14, 2026

With new data, Regenxbio to seek FDA approval of Duchenne gene therapy

Though two serious side effects muddied the results, CEO Curran Simpson expressed optimism about a clearance and claimed FDA leadership will have a “mandate on rare disease flexibility.”

By Ben Fidler • May 14, 2026

Lilly data point to ‘maintenance’ strategies for GLP-1 weight loss

A pair of trial results published in medical journals suggest switching from high-dose injectables to lower doses or pills could help people with obesity keep their weight down over the long term.

By Kristin Jensen • May 13, 2026

[Podcast] Closing the Distance in Cancer Care

This podcast episode explores the critical role community oncology plays in the U.S. healthcare system and why supporting its growth and autonomy matters for patients and providers.

May 13, 2026

Entrada shares dive as Duchenne results disappoint

While the company claimed a victory, analysts said data from a Phase 1/2 study fell short of expectations. Entrada shares subsequently tumbled more than 50%.

By Kristin Jensen • May 7, 2026

Viridian data lift prospects for thyroid eye disease drug

Whereas earlier Phase 3 results disappointed Wall Street, new findings in people with “chronic” disease were viewed by analysts as much more competitive with Amgen’s Tepezza.

By Delilah Alvarado • May 5, 2026

Cytokinetics heart drug scores in closely watched trial

Myqorzo’s success in “non-obstructive” hypertrophic cardiomyopathy separates it from Bristol Myers Squibb’s rival Camzyos and opens up a multibillion-dollar market opportunity.

By Ben Fidler • May 5, 2026

Celcuity strengthens case for ASCO-spotlighted breast cancer drug

The new data could support a broader approval submission for a therapy that is already under review and set to be showcased at the year’s biggest meeting for cancer research.

By Delilah Alvarado • May 4, 2026

Boehringer dual-acting obesity shot hits mark in Phase 3 trial

Survodutide spurred weight loss Wall Street analysts referred to as “Wegovy-like,” and showed signs it might help preserve muscle mass as well.

By Jonathan Gardner • April 28, 2026

Oruka surges as long-acting psoriasis drug shows early promise

A therapy that works similarly to AbbVie’s blockbuster Skyrizi appeared more potent in a mid-stage trial and has the potential to be dosed less frequently. 

By Delilah Alvarado • April 27, 2026

Veradermics soars on positive data for baldness treatment

The results could support the first approval in decades for an oral medicine that can treat male pattern baldness, though the therapy will face competition from generics and over-the-counter medications.  

By Jonathan Gardner • April 27, 2026

Intellia CRISPR drug succeeds in late-stage study against rare swelling disorder

The findings position Intellia to bring to market the first “in vivo” gene editing medicine, though the therapy’s commercial potential remains the source of intense investor debate.

By Ben Fidler • April 27, 2026

Revolution drug shows promise in early pancreatic cancer

The findings build on data suggesting Revolution’s therapy could upend treatment for a notoriously tough-to-treat tumor and generate billions in sales.

By Jonathan Gardner • April 22, 2026

Moderna, after losing US funding, rebounds to start mRNA bird flu vaccine trial

A program that got caught up in HHS’ decision to abandon mRNA research was revived by a public-private coalition and is now beginning a large, late-stage test that could support a future approval.

By Kristin Jensen • April 22, 2026

Merck’s fast-ascending kidney cancer drug hits a setback

Welireg’s failure in first-line kidney cancer removes a blockbuster opportunity and could leave an opening for a rival drug from Arcus Biosciences, analysts said.

By Ben Fidler • April 21, 2026

AACR 2026: Revolution’s next prospect, Merck’s reveal and a lung cancer battle

Featured at this year’s meeting on early cancer research were results from an immunotherapy Merck acquired in 2024 and several targeted medicines for lung tumors.

By Ben Fidler • April 20, 2026

[Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services

This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.

By BioPharma Dive's studioID • Updated May 26, 2026

Lilly’s new obesity pill passes heart safety test in diabetes

The findings, which come amid FDA scrutiny of Foundayo’s safety, will enable Lilly to seek a new clearance in diabetes.

By Jonathan Gardner • April 16, 2026

FDA asks Lilly to evaluate obesity pill’s liver risk

The request, which is part of a just-released approval letter for Foundayo, comes amid an intensifying marketing battle between Lilly and Novo.

By Jonathan Gardner • April 15, 2026

Spyre drug for inflammatory bowel disease shows promise in early study

The therapy, which works similarly to Takeda’s blockbuster Entyvio, showed remission rates that suggest a “best-in-class” profile, the company said. 

By Delilah Alvarado • April 13, 2026

Revolution pancreatic cancer drug nearly doubles survival in key trial

The subject of buyout rumors this year, Revolution posted Phase 3 results one analyst called a “game changer” in a tough-to-treat tumor. 

By Jonathan Gardner • April 13, 2026

Rethinking dermatology trial design for late-stage success

A smarter approach to dermatology trials—built for durability and real-world impact.

April 13, 2026