Structure’s GLP-1 pill shows ‘best-in-class’ potential in obesity trial

Testing revealed weight loss effects some Wall Street analysts believe compare favorably to Lilly’s orforglipron, which regulators could approve within weeks. 

By Jonathan Gardner • March 16, 2026

Biogen builds case for Spinraza successor with fresh data

More early-stage data show the drug, called salanersen, appeared to have positive effects on neurodegeneration and motor function in patients previously treated with Novartis' Zolgensma.

By Gwendolyn Wu • March 11, 2026

Explore the Trendline➔

Vaccine development

Vaccine developers are investing in shots for RSV, influenza and pneumococcal disease in a newly uncertain regulatory climate.

By BioPharma Dive staff

Bimzelx tops Skyrizi in head-to-head psoriatic arthritis trial

UCB said it’s the first time an approved biologic demonstrated superiority over an IL-23 blocker in psoriatic arthritis. Yet analysts aren’t sure how commercially impactful the results will be.

By Delilah Alvarado • March 11, 2026

Vertex kidney disease drug hits mark in late-stage study

Company shares surged in after-market trading on results for a drug Vertex acquired in a multibillion-dollar deal and sees as having “best-in-class potential” in a competitive field.

By Ben Fidler • Updated March 10, 2026

Roche’s prized breast cancer pill fails closely watched study

The result “pulls the rug” out from under giredestrant, according to one analyst, sparking another share selloff following disappointing obesity data last week.

By Jonathan Gardner • March 9, 2026

Ipsen to withdraw cancer drug acquired in buyout due to safety concerns

Ipsen found cases of secondary malignancies in a confirmatory study of Tavzerik, a medicine it got in a purchase of Epizyme and that it has struggled to sell. 

By Delilah Alvarado • March 9, 2026

Roche, Zealand shares fall on ‘undifferentiated’ obesity drug results

An amylin-targeting medicine at the center of the companies’ multibillion-dollar alliance spurred less weight loss than investors had hoped, leading some analysts to question its ability to stand out. 

By Delilah Alvarado • March 6, 2026

FDA issues speedy approval to J&J’s Tecvayli-Darzalex combo

The regimen’s clearance in early multiple myeloma was the third approval under the agency’s controversial “national priority” voucher program and issued only 55 days after the review began.

By Jonathan Gardner • March 6, 2026

PepGen muscular dystrophy drug gets ‘surprise’ hold from FDA

The agency acted after reviewing mouse data submitted in 2024, making the timing of the new pause “confusing,” one analyst wrote.

By Kristin Jensen • March 5, 2026

Blackstone puts $400M into Teva, Sanofi gut disease drug

The deal adds to a growing biotech presence for Blackstone and supports testing of a drug competing with rival therapies from Merck and Roche.

By Jonathan Gardner • March 4, 2026

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

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