Muscle-sparing obesity drug safe for Phase 3 trial, Veru says

The company is preparing a Phase 3 trial of enobosarm with a novel formulation that could extend its patent life.

By Jonathan Gardner • May 28, 2025

GSK-licensed antibiotic meets goal in late-stage study

The British drugmaker may have succeeded in reviving an oral antibiotic previously rejected by the FDA when it was under development at Spero.

By Kristin Jensen • May 28, 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

[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

Agile biopharma firms are driving breakthroughs. Learn how they ensure clinical trial success in this podcast.

By BioPharma Dive's studioID • May 28, 2025

Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung cancer, according to one physician.

By Jonathan Gardner • May 22, 2025

From insight to impact: How eCOAs strengthen trial data quality

Timely, high-integrity insights for sponsors that reduce risk and move trials forward.

By IQVIA • May 19, 2025

Women’s health faces growing headwinds, despite jump in venture investment

While venture funding is rising, federal policy upheaval may affect women’s health research more acutely than other fields, one biotech CEO said.

By Delilah Alvarado • May 13, 2025

iTeos, GSK to shelve TIGIT drug after study setback

The failure is the latest stumble for a cancer drug class that hasn’t lived up to expectations. iTeos will begin a strategic review in response. 

By Ben Fidler • May 13, 2025

Viatris’ new form of old pain drug scores in large trials

A version of meloxicam designed to work faster has beat out a placebo in two late-stage studies focused on post-surgical acute pain. Viatris now plans to file for approval this year.

By Jacob Bell • May 8, 2025

Biotech is guessing how Vinay Prasad might change the FDA. His research, writing offer clues.

CBER’s new chief has argued for more stringent measures of assessing drugs for cancer and rare diseases, suggesting he might push for higher standards in the review of medicines under his division's purview.

By Jonathan Gardner • May 8, 2025

AstraZeneca quietly exits neuroscience

The company removed experimental drugs for Alzheimer’s, migraine and pain from its pipeline to focus more resources on “core therapeutic areas” and “high value” programs.

By Jacob Bell • May 1, 2025

New Akeso, Summit data stir debate on PD-1/VEGF drugs

Interim results from a study in China suggest ivonescimab may reduce the risk of death versus Keytruda, but the difference wasn’t statistically significant.

By Ben Fidler • April 28, 2025

Bristol Myers’ prized schizophrenia drug stumbles in testing

A late-stage study found Cobenfy wasn’t better than a placebo as an add-on to atypical antipsychotics. Some analysts view the failure as a “significant hit” to the drug’s commercial outlook.

By Jacob Bell • April 23, 2025

Enhertu combo tops standard drugs in first-line HER2 breast cancer

The data could help the Enhertu regimen overtake a drug combination that’s been used as the initial treatment for HER2-positive breast tumors for more than a decade.

By Ben Fidler • April 21, 2025

Lilly’s obesity pill scores in large diabetes trial

The drug, orforglipron, helped people with diabetes reduce their blood sugar levels while spurring significant weight loss, swelling Lilly's market value by more than $100 billion.

By Jonathan Gardner • Updated April 21, 2025

New research kindles excitement around stem cell therapies for Parkinson’s

Two studies published in Nature found stem cell-derived products can not only be safely transplanted into the brain, but also show promising — albeit unproven — signs of efficacy.

By Jacob Bell • April 16, 2025

Bristol Myers stumbles in bid to widen heart drug’s use

Camzyos’ failure in a form of hypertrophic cardiomyopathy dampened its commercial outlook and spurred debate as to whether other drugs like it would similarly struggle in testing.

By Ben Fidler • April 15, 2025

Safety worries spur Pfizer to drop another obesity pill

Signs of potential liver damage in a study participant led the company to abandon danuglipron, a drug it hoped would help it break into the highly lucrative market for obesity drugs.

By Jonathan Gardner • April 14, 2025

Verve’s second swing at gene editing for heart disease shows early promise

Wall Street analysts said the results for Verve’s therapy appeared competitive on efficacy, while avoiding any major safety concerns — at least so far.

By Ben Fidler • April 14, 2025

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

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