FDA Approval

With a key depression drug nearing Phase 3 and more data imminent, AtaiBeckley is set to make its case to Wall Street at three major March conferences.

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 new study uses PET-CT scans to track CIT-013, a first-in-class antibody targeting the root cause of inflammation in rheumatoid arthritis and HS.

Nicox's novel glaucoma drug NCX 470 receives positive FDA feedback, keeping its 2026 U.S. market submission on track to challenge a $7B industry.

Appili Therapeutics lands a $40M deal to fight fungal threats, but with cash reserves low and loans due, can its science outpace its financial pressures?

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.

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

A new diagnostic tool for interstitial lung disease receives FDA Fast Track, promising earlier, more accurate detection of deadly lung inflammation.

A non-invasive device for spinal cord injury gains major international praise, signaling a shift in neurorehabilitation and a path to market.

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.

With its Phase 1 trial fully enrolled, Senti Bio’s logic-gated CAR-NK therapy shows deep, durable remissions, charting an expedited path for R/R AML.

With FDA Priority Review, Takeda's oveporexton could be the first drug to target the root cause of narcolepsy, offering transformative hope for patients.

Bolstered by a top regulatory expert and unique veterinary data, Vivos Inc. is set to file for human trials of its precision injectable cancer treatment.

Kincell Bio and RegCell partner to bring a groundbreaking, non-gene-edited Treg cell therapy for autoimmune diseases from the lab to clinical trials.

Belgian biotech Agomab Therapeutics secures $200 million in its Nasdaq debut, fueling its mission to develop therapies for debilitating fibrotic conditions.

With five conferences in its sights, Voyager Therapeutics is making a major push to win over investors ahead of a pivotal year for its neurological pipeline.

IN8bio promotes Kate Rochlin to President, signaling a strategic push to advance its promising gamma-delta T cell pipeline amid a challenging market.

With a promising spinal cord injury drug nearing late-stage trials, NervGen appoints interim leader Dr. Adam Rogers as permanent CEO to guide the breakthrough.

EMD Serono and the Trump Administration launch a new program offering massive discounts on IVF drugs, bringing hope to millions of aspiring parents.