FDA Approval

With a bolstered cash runway from recent funding, Inventiva is all-in on its MASH drug, lanifibranor, racing against giants in a multi-billion dollar market.

A Swedish biotech and Belgian university secure major EU funding to advance a first-in-class drug against glioblastoma, a notoriously deadly brain tumor.

With a novel glutamate-targeting drug and a €38M cash injection, Newron aims to transform care for treatment-resistant schizophrenia.

With no approved nonsurgical options for plantar fibromatosis, Keenova's new study and late-stage trial offer a significant glimmer of hope for sufferers.

A landmark trial shows Retevmo significantly cuts cancer recurrence in early-stage patients, pushing for a new standard of care and early genetic testing.

A landmark trial for Roche’s Gazyva shows unprecedented success in treating primary membranous nephropathy, offering hope of preventing kidney failure.

Iterum Therapeutics secures key Medicare access for its antibiotic ORLYNVAH™, but a costly FDA trial requirement for a new use casts a shadow on its future.

Alto Neuroscience completes enrollment for a trial of its skin patch drug, ALTO-101, offering new hope for the millions battling cognitive decline in schizophrenia.

After its lead anxiety drug failed a key trial, Vistagen turns to AI and a new menopause treatment to secure its future. Can the company recover?

Aethlon Medical advances its Hemopurifier for oncology and Long COVID, but a shrinking cash reserve and rising quarterly loss test its lean science strategy.

After a major trial failure tanked its stock, Rezolute pins its hopes on a second drug program and a crucial FDA meeting to chart a path forward.

A new oral drug, IMSB301, offers hope for Aicardi Goutières Syndrome, a devastating rare disease with no cure, in a pivotal new clinical trial.

Clinical-stage biotech BioVie announces its novel anti-inflammatory drug, bezisterim, will be featured at a key psychiatric conference for its potential.

With promising new data for its cancer and obesity pipeline, Corbus Pharmaceuticals prepares for a crucial investor presentation at the Oppenheimer conference.

Australian biotech Amplia Therapeutics is bringing its promising pancreatic cancer trial to the US, a key step in developing a drug that targets the disease's defenses.

After a decade-long battle with Stage 4 cancer, one patient's cure spotlights a revolutionary immunotherapy and its potential to change cancer treatment.

Following key FDA progress for its oral osteoporosis drug, Entera Bio's CEO and board members are buying up company stock, signaling deep confidence.

A new collaboration with Datavant will securely connect real-world health data, aiming to speed up research and deliver life-saving therapies faster.

Health Canada grants conditional approval to BioMarin's VOXZOGO, the first drug in the country to target the genetic cause of achondroplasia.

Zelluna partners with Medpace for a first-in-human trial of its ZIMA-101 TCR-NK therapy, a new 'off-the-shelf' approach for hard-to-treat solid tumors.