Pharvaris’ pill succeeds in late-stage trial for rare swelling disorder

Phase 3 data could make the Dutch biotech's drug competitive in the increasingly crowded market of hereditary angioedema treatments.

By Jonathan Gardner • Dec. 3, 2025

FDA details plan to scale back animal tests for some antibody drugs

The draft guidance issued Tuesday comes as regulators and policymakers have looked for ways to aid U.S. drugmakers amid fast progress by their China-based counterparts.

By Jonathan Gardner • Dec. 2, 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

Belite continues ascent as Stargardt drug hits mark in late-stage trial

The results position Belite, one of the sector’s top-performing companies since 2022, to seek approval of what could be the first marketed medicine for the rare eye condition.

By Ben Fidler • Dec. 1, 2025

Expanding access in oncology trials: The case for a paired tissue-plasma approach

Paired tissue-liquid biopsy: A smarter path to faster enrollment and better trial outcomes. 

Dec. 1, 2025

Novartis cuts hundreds of jobs; Novo’s dual-acting diabetes drug heading to Phase 3

The layoffs affect Swiss manufacturing facilities. Elsewhere, the FDA pushed back an approval deadline and a mid-stage study showed Novo’s amycretin helps regulate blood sugar.

By BioPharma Dive staff • Nov. 26, 2025

Kelun, Merck tout ADC as potential first-line treatment in lung cancer

The partners said a TROP2-targeting antibody drug conjugate succeeded in a late-stage trial, paving the way for potential approval in the first-line setting.

By Delilah Alvarado • Nov. 25, 2025

Bayer’s experimental blood-thinner notches trial win in stroke prevention

Asundexian's Phase 3 study results raise hopes for a new class of cardiovascular drugs that has seen clinical setbacks.

By Jonathan Gardner • Nov. 24, 2025

Novo Nordisk’s GLP-1 misses goal in closely watched Alzheimer’s studies

The studies offer perhaps the most concrete rebuttal yet to an idea that GLP-1 drugs, which have profound benefits on weight loss and heart health, might also help combat neurodegeneration.

By Jacob Bell • Nov. 24, 2025

A brain biotech’s top drug fails against MS

Shares of Contineum Therapeutics dipped by the double-digits late Thursday after investors learned of a clinical setback for a drug that’s also piqued Johnson & Johnson’s interest.

By Jacob Bell • Nov. 21, 2025

Agios shares fall on mixed sickle cell results for blood disease drug

Pyrukynd, which Agios sells for a rare type of anemia, missed one of its main objectives in a study seen as crucial for its commercial outlook and the company’s reinvention as a rare disease specialist.

By Jonathan Gardner • Nov. 19, 2025

Roche pill notches win in early breast cancer

Roche claimed the results make its drug giredestrant the first of its kind, a so-called oral SERD, to show a benefit in the “adjuvant” setting after surgery. 

By Jonathan Gardner • Nov. 18, 2025

The inspection-ready operating model for clinical trials

Turn readiness into routine with roles, controls and audit trails across systems.

By IQVIA Technologies • Nov. 17, 2025

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

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