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

Explore the Trendline➔

Neuroscience drug development

Enthusiasm is running higher among drugmakers and investors for neuroscience drug development, buoyed by recent approvals of new Alzheimer’s, ALS and depression medicines.

By BioPharma Dive staff

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

Corvus shares nearly triple on positive data for eczema pill

While early, the results indicate drugs known as ITK inhibitors have the potential to match or surpass the efficacy observed with the injectable biologic Dupixent.

By Jonathan Gardner • Jan. 21, 2026

When every day counts: Building CRO partnerships on a foundation of trust, care and precision

Clinical trial delays impact outcomes. Learn why CROs need a supply chain partner they can trust to reduce delays and help patients. 

Jan. 20, 2026

The patient retention crisis is happening before enrollment even begins

The biggest patient drop-off happens before patients ever enroll.

By Katie Rodammer • Jan. 20, 2026

Tecvayli tops standard drugs in early multiple myeloma, J&J says

The results build on evidence U.S. regulators found so compelling last year they proactively awarded J&J a new kind of drug review voucher. 

By Jonathan Gardner • Jan. 15, 2026

What Sanofi’s multiple sclerosis troubles could mean for the space

Regulatory and clinical roadblocks have set back its oral BTK inhibitor tolebrutinib, but the drug class still has many opportunities to make an impact.

By Kelly Bilodeau • Jan. 13, 2026

Best practices for COA selection: Building a stronger foundation for clinical trials

In a time when COAs are more nuanced, critical and complex than ever, researchers can turn to best practices to move forward efficiently while maintaining scientific and regulatory rigor.

Jan. 12, 2026

GSK, Ionis claim study success for RNA-based hepatitis B drug

The companies didn’t provide details, but said global regulatory filings are now planned for the therapy, an oligonucleotide meant to provide “functional cures” for chronic hepatitis B infections.

By Kristin Jensen • Jan. 7, 2026

Alumis soars as TYK2 drug hits mark in psoriasis trials

Shares more than doubled in value after Phase 3 results suggested Alumis’ pill may compare favorably with other emerging oral options for psoriasis, among them drugs from Takeda and Johnson & Johnson.

By Jonathan Gardner • Jan. 6, 2026

Zenas shares crash after top drug misses expectations in immune disease study

While the company’s bispecific medication obexelimab met its objectives in a trial in IgG4-related disease, it didn’t appear to match the effectiveness of a recently approved Amgen drug.

By Jonathan Gardner • Jan. 5, 2026

Strategic diagnostic testing partnerships are accelerating clinical research

With the rise of biologics, precision medicine and AI-driven drug discovery, clinical research has entered a new and complex era.

Jan. 5, 2026

10 clinical trials to watch in the first half of 2026

After a lengthy downturn, the biotech industry finally gathered momentum in 2025. Key readouts in obesity, infectious disease and many rare conditions could help it continue.

By BioPharma Dive staff • Jan. 5, 2026

Patient deaths put Merck, Daiichi’s ADC trial on partial hold

The FDA placed the hold after researchers recorded a “higher than anticipated” incidence of deaths in a study testing “I-DXd” in people with small cell lung cancer.

By Delilah Alvarado • Dec. 19, 2025

Novo files for CagriSema approval; Merck and Pfizer’s trial win

Novo Nordisk's application for CagriSema comes at the same time as competitor Eli Lilly's ask for its obesity drug orforglipron. Elsewhere, Merck & Co. and Pfizer succeeded in a bladder cancer study.

By BioPharma Dive staff • Dec. 19, 2025

Galapagos TYK2 drug hits goal in one trial, misses in another

The Belgian biotech is still on the hunt for partners after reporting that its drug succeeded against an inflammatory skin and muscle disorder but missed in a lupus study.

By Jonathan Gardner • Dec. 19, 2025

Lilly obesity pill, headed for quick FDA review, hits mark in ‘maintenance’ trial

Orforglipron helped keep weight down when used after initial therapy with an injectable, a new treatment strategy that could broaden its use in obesity. 

By Jonathan Gardner • Dec. 18, 2025

Insmed’s ‘win streak’ ends as top drug fails study in chronic nasal condition

The company’s valuation, which surged past $40 billion this year, fell by almost a fifth on a dimmer outlook for its closely followed lung disease medicine.

By Kristin Jensen • Dec. 18, 2025

Takeda says $4B TYK2 drug succeeds in large psoriasis studies

The results position Takeda, which acquired its therapy in one of the industry’s larger single-drug acquisitions, to challenge Bristol Myers Squibb’s Sotyktu.

By Ben Fidler • Dec. 18, 2025

Developing a path forward in cancer cachexia

Pfizer scientists have been working to advance understanding of – and potential treatments for – cachexia.

Dec. 16, 2025

Nektar sees silver lining as autoimmune drug ‘narrowly’ misses in alopecia study

Despite being unable to declare statistical success, the company claimed its therapy showed enough promise to support moving into late-stage testing. 

By Kristin Jensen • Dec. 16, 2025

Argenx falters in effort to expand immune drug’s use

The company will stop two trials testing its blockbuster therapy Vyvgart in thyroid eye disease after treatment was judged to be ineffective at an interim checkpoint.

By Jonathan Gardner • Dec. 15, 2025

Sanofi MS drug hits two setbacks

Tolebrutinib, which Sanofi acquired in a $3.7 billion buyout, failed a Phase 3 study in “primary progressive” multiple sclerosis and is facing a delayed U.S. approval decision in another form of the disease.

By Jacob Bell • Dec. 15, 2025

Kyverna to seek first clearance of a CAR-T therapy for autoimmune disease

The company intends to file a U.S. application in the first half of 2026 following positive study results in a condition called stiff person syndrome that has no approved therapies. 

By Ben Fidler • Dec. 15, 2025