Novartis notches another win for drug acquired in MorphoSys deal

Ianalumab, which has already succeeded in testing against Sjogren’s syndrome, proved impactful in a condition that causes low platelet counts.

By Jonathan Gardner • Dec. 9, 2025

FDA raises CAR-T approval standards; Novartis bets on an AI startup

CAR-T cancer therapies now need to succeed in randomized, controlled trials to earn approvals. Elsewhere, a drug from Bristol Myers Squibb and BioNTech proved effective in breast cancer patients.

By BioPharma Dive staff • Dec. 9, 2025

Explore the Trendline➔

Radiopharmaceuticals

A series of technological advances have led to an explosion of scientific progress — and dealmaking — involving medicines that can precisely deliver radioactive materials into tumors.   

By BioPharma Dive staff

J&J’s ‘remarkable’ Tecvayli data support earlier use in multiple myeloma

In a step forward for bispecific antibodies, study results presented at ASH suggest a Tecvayli-based combination could have curative potential early in a patient’s disease course.

By Jonathan Gardner • Dec. 9, 2025

Terns drug shows potential to challenge Novartis’ blockbuster leukemia treatment

While early, study results presented at ASH show Tern’s drug could surpass Novartis’ Scemblix and “raise the bar in efficacy” for chronic myeloid leukemia medicines, the company’s CEO said.

By Jonathan Gardner • Dec. 8, 2025

At ASH, Lilly makes case to widen Jaypirca use in leukemia, lymphoma

In a head-to-head trial, Lilly’s drug was as effective as Imbruvica at inducing responses and displayed certain safety advantages that could make it a preferred treatment in early lines of care. 

By Jonathan Gardner • Dec. 7, 2025

Vertex CRISPR therapy hits early goal in children with blood disorders

Casgevy, now a "national priority" drug, helped kids with sickle cell and beta thalassemia, results which may help toward a label expansion and stronger commercial uptake.

By Jonathan Gardner • Dec. 6, 2025

12 former FDA chiefs blast Prasad’s move to toughen vaccine standards

In an article published in NEJM, nearly all living ex-FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.

By Jonathan Gardner • Dec. 4, 2025

After finding ‘irregularities,’ Bristol Myers to extend key trial of Cobenfy in Alzheimer’s psychosis

Data from the "ADEPT-2" study, which analysts had hoped would arrive before year's end, are now expected sometime in 2026.

By Jacob Bell • Dec. 3, 2025

Capricor soars on positive results for Duchenne cell therapy

Shares quadrupled now that the company appears on track to reverse an earlier FDA rejection of what could be the first treatment for heart-related complications of Duchenne.

By Kristin Jensen • Dec. 3, 2025

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

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