FDA plans to phase out animal testing for some drugs

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin Makary was sworn in.

By Ned Pagliarulo • April 11, 2025

Tempest seeks strategic alternatives as cash runs out for Phase 3 trial

Amid a funding drought for startups, the company is looking for a deal that can advance its liver cancer drug.

By Jonathan Gardner • April 10, 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

Rallybio discontinues lead drug for rare maternal disorder

The company has decided to switch gears following disappointing data for a monoclonal antibody targeting a rare maternal blood disorder.

By Delilah Alvarado • April 8, 2025

Lilly study data reinforce potential of new kind of heart drug

Drugs from Novartis, Amgen and now Lilly have proven powerfully effective at reducing Lp(a). Whether that will translate to a cardioprotective benefit won’t be answered until Phase 3 tests read out.

By Ned Pagliarulo • March 31, 2025

Wave to seek approval of Duchenne drug after mid-stage study data

The company plans to file next year for an accelerated clearance of its "exon-skipping" treatment, which would compete with one of Sarepta's medicines.

By Kristin Jensen • March 26, 2025

Merck bets $200M on a new type of heart pill

A licensing deal with Jiangsu Hengrui Pharmaceuticals puts Merck in a competitive race to develop a medicine that targets a genetic risk factor called lipoprotein(a). 

By Jonathan Gardner • March 25, 2025

Novo adds to obesity drug pipeline via $200M deal with China-based biotech

The licensing pact adds a second so-called "triple agonist" to the Danish drugmaker's portfolio as competition with Lilly and other contenders heats up.

By Jonathan Gardner • March 24, 2025

Accelerate oncology drug development: A data-driven approach to clinical decisions

Speed vs. success in oncology trials: Discover data-driven strategies to accelerate drug development.

March 24, 2025

Academic medical centers say funding cuts jeopardize health research

Proposed cuts to National Institutes of Health funding threaten innovation necessary to fuel advances in patient care, researchers and provider groups say.

By Susanna Vogel • March 21, 2025

Novartis builds case for new SMA gene therapy

To Novartis, fresh late-stage data support the idea that its intrathecal drug, which has the same active ingredient as Zolgensma, could be approved for a broad range of spinal muscular atrophy patients.

By Jacob Bell • March 20, 2025

Immunovant claims study success for immune disease drug but holds off on submission

The company continues to focus on a next-generation drug while batoclimab’s testing in thyroid eye disease wraps up.

By Kristin Jensen • March 19, 2025

Prime sets sights on liver, lung disease as next target for its gene editing tech

The biotech unveiled a new research program in alpha-1 antitrypsin deficiency, a disease that’s also a focus for rival Beam Therapeutics.

By Ned Pagliarulo • March 18, 2025

Orca Bio to seek approval of T cell transplant after positive trial data

Results showed Orca’s treatment, a purified mix of donor-derived T cells and stem cells, was safer than standard transplant in treating certain blood cancers.

By Ned Pagliarulo • March 17, 2025

Arvinas gets positive breast cancer data, but finds differentiation a hard sell

Trial results show vepdegestrant, a protein-degrading drug Arvinas is developing with Pfizer, improved on fulvestrant in a subgroup of breast cancer patients, but not the overall study population.

By Ned Pagliarulo • March 11, 2025

Novo’s Wegovy successor disappoints in second large trial

A study in people with obesity and diabetes again found CagriSema helps people lose weight, but not by enough to clearly surpass Eli Lilly’s Zepbound.

By Jonathan Gardner • March 10, 2025

Mineralys shares climb on study data for blood pressure drug

Findings from a pair of studies in tough-to-treat hypertension establish Mineralys’ drug as a “derisked, almost-commercial stage cardiometabolic asset,” wrote one analyst firm following the company.

By Ben Fidler • March 10, 2025

J&J scraps depression testing for potential blockbuster drug

Analysts say the decision is a “big blow” to a once-promising class of brain therapies that include’s J&J’s aticaprant and a drug from Neumora.

By Jacob Bell • March 7, 2025

Tris to ask for approval of dual-acting pain drug

Positive data from a pair of acute pain studies convinced the company that its drug, which works differently than existing medications, has a good shot at reaching market.

By Jacob Bell • March 6, 2025

Blocking PD-1 and VEGF: The bispecific cancer drugs that could best Keytruda

Striking study results last year indicated a new type of medicine may improve on Merck’s immunotherapy, spurring a wave of research practically overnight.

By Ben Fidler • March 4, 2025

Protagonist says Takeda-partnered drug succeeds in rare blood cancer

Takeda paid Protagonist $300 million one year ago to license rights to rusfertide, which the companies are developing to treat polycythemia vera.

By Ned Pagliarulo • March 3, 2025

Summit partners with Pfizer to study bispecific, ADC combinations

The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug conjugates in hopes of finding “potentially landscape-changing combinations.”

By Jonathan Gardner • Feb. 24, 2025

Sanofi, Teva add to case for new bowel disease drug

Detailed results presented at a medical congress help reinforce analyst expectations the drug, called duvakitug, will be competitive with other Crohn’s, colitis medicines in testing.

By Ned Pagliarulo • Feb. 24, 2025

Partnering for success in early phase clinical development

Early-phase clinical trials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.

Feb. 24, 2025

Solid says early data suggest ‘differentiated’ Duchenne gene therapy

The company raised $200 million after early findings hinted its therapy could be more potent than others like it, including Sarepta Therapeutics’ Elevidys.

By Ben Fidler • Feb. 18, 2025

Sanofi to take $250M charge on study failure for E. coli vaccine

The French drugmaker said the vaccine it agreed to develop with Johnson & Johnson a year ago was “not sufficiently effective.”

By Kristin Jensen • Feb. 13, 2025