FDA, aiming to lower drug costs, moves to speed approval of biosimilars

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help developers bring them to market more quickly and cheaply. 

By Jonathan Gardner • Oct. 29, 2025

BridgeBio chalks up another win for its rare disease research

The company reported its second late-stage study success, this time with a drug that could become a new treatment standard for an uncommon endocrine disease.

By Ben Fidler • Oct. 29, 2025

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

Merck kidney cancer drug succeeds in two large trials

The results could help expand use of Welireg, one of the medicines Merck is counting on to drive revenue growth when its top-selling immunotherapy Keytruda loses patent protection. 

By Jonathan Gardner • Oct. 28, 2025

Intellia pauses two CRISPR drug studies after safety scare

A study volunteer receiving Intellia’s transthyretin amyloidosis treatment was hospitalized due to severe signs of liver stress, prompting the company to pause enrollment and dosing while evaluating a new safety protocol. 

By Jonathan Gardner • Oct. 27, 2025

BridgeBio to seek approval of limb-girdle drug following new study data

The company intends to meet with the FDA to discuss results that showed a level of improvement on a marker of muscle stability that one executive described as a “home run.”

By Ben Fidler • Oct. 27, 2025

Chugai buys a kidney biotech; ICER targets rising launch prices

Chugai is acquiring partial rights to a marketed IgA nephropathy drug. Elsewhere, ICER claimed Americans are often “overpaying” for medicines and Summit raised $500 million.

By BioPharma Dive staff • Oct. 24, 2025

Ventyx shares soar after study suggests cardiovascular benefits for experimental drug

The drug’s effects on cardiovascular and inflammation markers outshined its failure to spur weight loss, analysts wrote.

By Kristin Jensen • Oct. 23, 2025

Moderna says CMV vaccine once seen as future blockbuster fails key study

A shot analysts projected as a multibillion-dollar seller produced results “well below” the company’s expectations, heightening pressure on Moderna’s flagging respiratory vaccine business.

By Delilah Alvarado • Oct. 22, 2025

Sanofi drug acquired in buyout succeeds in rare disease trial

The drug’s success in a Phase 2 study in alpha-1 antitrypsin deficiency “validates” Sanofi’s 2024 acquisition of Inhibrx, according to one analyst.

By Delilah Alvarado • Oct. 22, 2025

Alector dementia drug, partnered with GSK, fails in key study

The negative readout led to a collapse in share price for Alector, which now plans to cut almost half of its workforce while refocusing and finding a new R&D leader.

By Kristin Jensen • Oct. 22, 2025

AstraZeneca, Daiichi’s Datroway excels in hard-to-treat breast cancer

Presented at the European Society for Medical Oncology, study results showed Datroway extended survival in breast cancer patients for whom immunotherapy is not an option.

By Delilah Alvarado • Oct. 20, 2025

Summit’s dual-acting drug scores lung cancer win

A closely watched trial in Chinese patients is raising hope that ivonescimab will outperform Keytruda in a large global study that could reshape first-line treatment regimens.

By Jonathan Gardner • Oct. 20, 2025

Exelixis shares dip on colorectal cancer data

Some on Wall Street weren’t too impressed with results from a pivotal trial that tested an Exelixis drug, zanzalintinib, in combination with Tecentriq.

By Jacob Bell • Oct. 20, 2025

Roche pill delays tumor progression in closely watched breast cancer study

Results presented at the European Society for Medical Oncology meeting could help separate Roche’s medicine from similar hormone-degrading drugs for breast tumors.

By Jonathan Gardner • Oct. 18, 2025

J&J claims success in study testing earlier Tecvayli use in multiple myeloma

The result marks a potential advance for dual-targeting antibody drugs like Tecvayli, which are currently relegated to later-line settings for the persistent blood cancer.

By Jonathan Gardner • Oct. 16, 2025

Lilly, battling skepticism, reinforces GLP-1 pill’s case with new study data

Some Wall Street analysts have questioned orforglipron’s sales outlook in obesity, but see great potential in diabetes, where on Wednesday it succeeded in two more late-stage trials. 

By Kristin Jensen • Oct. 15, 2025

[Podcast] The Progress Profile: Alzheimer’s Research in Focus

Discover the latest breakthroughs in Alzheimer's research, diagnosis, and prevention in this expert-led podcast series.

By BioPharma Dive's studioID • Oct. 15, 2025

Kailera nets $600M more to advance Zepbound-like obesity drug

Among the largest private biotech funding rounds this year, the financing will support global trials of an obesity shot that just succeeded in late-stage testing in China.

By Jonathan Gardner • Oct. 14, 2025

Pharma’s real-world data dilemma: Strategic asset or wasted resource?

To maximize RWD’s potential, pharma companies should begin with their business or clinical goals.

By Ilan Behm, VP, Real-World Data Engagement, Norstella and Ted Search, General Manager, Real-World Data, Norstella • Oct. 13, 2025

Maximizing biomarker insights from minimal samples

Unlock value with optimized workflows and scalable technologies.

Oct. 13, 2025

Regeneron, with ‘game-changing’ new data, to seek approval of hearing loss gene therapy

Study results published in The New England Journal of Medicine show the therapy significantly improved hearing in nearly a dozen children with a rare, genetic form of deafness.

By Jacob Bell • Oct. 12, 2025

AstraZeneca, Daiichi drug extends survival in hard-to-treat breast cancer

The results could pave the way for Datroway to supplant chemotherapy in certain triple-negative tumors, adding to existing clearances in other breast and lung malignancies.

By Delilah Alvarado • Oct. 6, 2025

Skye shares crash as obesity drug falls short in key study

The findings are the latest setback for weight loss medicines that target a specific cannabinoid receptor and are meant to boost the effects of incretin therapies like Wegovy.

By Ben Fidler • Oct. 6, 2025

The advantage of engaging patient recruitment partners as strategic allies, not emergency backups

The secret to on-time trials? Engaging recruitment partners early.

By Ryan Day and Steve Wimmer • Oct. 6, 2025

Amgen claims ‘landmark’ study result that could widen heart drug’s use

In a first-of-its-kind finding, Amgen’s PCSK9 drug protected heart health when tested as a “primary prevention” therapy, which could pave the way for access to a much broader population. 

By Jonathan Gardner • Oct. 2, 2025