Bristol Myers, J&J’s new blood thinner fails first big test

Milvexian’s failure in acute coronary syndrome dampens the outlook for other anticoagulants like it and is the latest in a series of clinical setbacks this year for Bristol Myers.

By Jonathan Gardner • Nov. 14, 2025

Korro to cut staff, shift strategy as RNA editing drug misses mark in early testing

Korro’s lead program for alpha-1 antitrypsin deficiency wasn’t as potent as anticipated, leading the company to change course and lay off a third of its workforce.

By Kristin Jensen • Nov. 13, 2025

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

Novartis, with study success, to seek approval of new kind of malaria drug

The treatment — which could be the first novel antimalarial in decades — showed the ability in testing to combat drug resistance and slow disease transmission.

By Delilah Alvarado • Nov. 12, 2025

Neurocrine chalks up a depression drug failure

Analysts suspected that the mid-stage trial miss wouldn't ding Neurocrine’s share price since expectations around the program were "near-zero."

By Jacob Bell • Nov. 10, 2025

Roche’s MS tablet scores in late-stage studies

The drug appears effective against both “relapsing” and “primary progressive” forms of the disease, though some analysts question if Roche has collected enough data to ask for approval in the latter.

By Jacob Bell • Nov. 10, 2025

Merck showcases data suggesting PCSK9 pill might rival cholesterol-lowering shots

Merck’s pill, which could be the first oral PCSK9 drug to get to market, displayed similar effects on lipid levels as injectable medicines from Amgen and Regeneron.

By Jonathan Gardner • Updated Nov. 10, 2025

Pharma’s clinical trial diversity push faces a new threat

Skyrocketing healthcare costs could deliver another blow to the industry’s ongoing quest to boost representation in R&D.

By Meagan Parrish • Nov. 7, 2025

Sarepta Duchenne drugs come up short in confirmatory test

Still, CEO Doug Ingram claimed removing the two drugs, Vyondys 53 and Amondys 45, from market would make “little sense” and that the evidence accrued to date makes a strong case for full approval.

By Ben Fidler • Nov. 4, 2025

Caribou results suggest renewed promise for ‘off-the-shelf’ cancer cell therapy

While early, the data support Caribou’s plan to boost its therapies’ effectiveness by using donor cells that are carefully matched to a patient’s immune system. 

By Jonathan Gardner • Nov. 3, 2025

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

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