Kyowa Kirin abandons touted eczema drug following safety review

A month after Amgen gave up on rocatinlimab — which was once seen as a threat to Dupixent — new findings have linked the drug’s mechanism to the onset of a type of skin cancer.

By Delilah Alvarado • March 3, 2026

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

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Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

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

Safety concerns spur Aardvark to halt key Prader-Willi drug trial

The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months before an expected data readout.

By Ben Fidler • March 2, 2026

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

Novo, searching for a spark, spotlights new data for three-pronged obesity drug

Novo’s answer to a closely watched Lilly drug spurred roughly 20% weight loss after 24 weeks in a Phase 2 trial, results one of its executives claimed to be “differentiating.”

By Ben Fidler • Feb. 24, 2026

Grail’s multi-cancer early detection test misses study goal

Shares in the company lost about half their value in Friday trading after use of the test wasn’t associated with a statistically significant reduction in late-stage cancer diagnoses.

By Susan Kelly • Feb. 20, 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

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

Compass, with Phase 3 hits, ready to take psilocybin to the FDA

The company plans to meet with the FDA to discuss a rolling approval application for “COMP360,” a synthetic form of psilocybin that could become the first “classic” psychedelic cleared for the U.S. market.

By Jacob Bell • Feb. 17, 2026

Ocular claims a win with eye drug data even as shares sink

Investors were looking for a greater difference between Ocular’s experimental medicine and a low-dose version of Eylea, analysts said.

By Kristin Jensen • Feb. 17, 2026

BridgeBio scores with dwarfism drug, setting up showdown with BioMarin, Ascendis

The latest in a string of clinical wins, the late-stage data gives the company strong footing to compete with BioMarin's top seller.

By Jacob Bell • Updated Feb. 12, 2026

Nektar, continuing comeback, says eczema drug’s effects hold up in follow-up study

The results vaulted Nektar’s market value to over $1 billion amid expectations the drug might prove a challenger to widely used medications like Dupixent. 

By Jonathan Gardner • Feb. 10, 2026

Hengrui, Kailera tout positive results for dual-acting obesity pill

Kailera CEO Ron Renaud claimed the weight loss effects and safety profile observed in the study suggest its therapy could eventually become a “differentiated treatment option” compared to other obesity pills.

By Delilah Alvarado • Feb. 9, 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

Pfizer dips on new data for obesity drug acquired in $10B deal

A long-acting shot Pfizer got through a buyout of Metsera appeared “slightly inferior” to Lilly’s market-leading Zepbound in a Phase 2 trial, one analyst said.

By Jonathan Gardner • Feb. 3, 2026

Novo combination obesity shot meets goal in diabetes trial

CagriSema’s blood sugar and weight reductions exceeded the company’s blockbuster Wegovy, yet the drug might still struggle to rival Lilly's Zepbound.

By Jonathan Gardner • Feb. 2, 2026

Sanofi drug, inherited from Genzyme, goes 1-for-2 in rare disease trials

The drug, which has suffered multiple setbacks over the years, could finally reach the market as a treatment for a form of Gaucher disease.

By Delilah Alvarado • Feb. 2, 2026

Amgen gives up on its once-prized eczema drug

The decision comes more than a year after disappointing initial Phase 3 results and casts further doubt on a class of autoimmune drugs thought to be challengers to treatments like Dupixent. 

By Jonathan Gardner • Jan. 30, 2026

FDA lifts hold on an Intellia CRISPR drug trial

Intellia is instituting new safeguards following the death of a study participant that led regulators to pause two trials in people with transthyretin amyloidosis. One of those tests remains suspended.

By Delilah Alvarado • Jan. 27, 2026

Roche, trailing in obesity, showcases new data for GLP-1 shot

A drug Roche acquired in a multibillion-dollar deal could be as effective as Zepbound, but may struggle to stand out in a crowded field, analysts said.

By Jonathan Gardner • Jan. 27, 2026

Sarepta, battling slowing sales, claims Duchenne gene therapy’s impact grows with time

On a Monday conference call, Sarepta CEO Doug Ingram said new long-term data should help “rebalance the discussion” surrounding Elevidys.

By Jonathan Gardner • Jan. 26, 2026

Sanofi to seek approval of touted eczema drug despite mixed results

Fresh data from multiple studies suggest the drug, which Sanofi has billed as a future blockbuster, could be cleared in the U.S. but has murky sales prospects.

By Jonathan Gardner • Jan. 23, 2026

FDA lays out new path to speed development of multiple myeloma drugs

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change that could accelerate cell therapies and other new medicines. 

By Jonathan Gardner • Jan. 22, 2026