Regulatory Approval

The firm's new ISO 42001 certification signals a major shift towards verifiable, trustworthy AI for the highly regulated life sciences industry.

With a major new investment, Cognito Therapeutics is pushing its non-invasive light and sound therapy for Alzheimer's toward a 2027 market launch.

Taiwanese biotech GNTbm's oral drug GNTbm-38, which turns 'cold' tumors 'hot', will begin Phase 1 trials for advanced and refractory cancers.

With FDA Breakthrough status for its MASH drug, a new CEO, and a fortified balance sheet, Altimmune is poised to take on serious liver disease and addiction.

With no approved treatments for the deadly pregnancy complication preeclampsia, one company's novel drug is now advancing to a crucial new clinical trial.

Biotech firm Immunis, Inc. secures a promising drug candidate to treat a debilitating side effect of Parkinson's therapy, offering hope to millions.

Early data for zolucatetide shows it shrinks tumors in a rare genetic disease, cracking a long-undruggable cancer target and offering new hope.

With a unique entry-blocking drug, Bioxytran targets COVID, flu, and RSV, moving toward a pivotal trial that could redefine antiviral treatment.

A new, smaller implant for back surgery promises easier procedures for surgeons and lasting relief for patients by tackling the risk of reherniation.

Cordis presents pivotal 12-month data for its innovative SELUTION SLR drug-eluting balloon, a device that could change how doctors treat clogged arteries.

A new growth medium aims to standardize stem cell production, addressing key regulatory and scalability challenges in the booming regenerative medicine market.

With strong revenue growth and critical FDA decisions on the horizon, MannKind's leadership prepares to outline its vision for investors in Miami.

With its lead drug for a rare blood cancer nearing European submission, Cellectar Biosciences advances its targeted radiotherapy platform on two fronts.

A new patented drug, budiodarone, aims to treat atrial fibrillation in heart failure patients, a group with few safe options. Is this the future of care?

As a deadly superbug spreads, BioVersys's BV100 enters late-stage trials, backed by promising data and a novel scientific approach to combat resistance.

A landmark Japan-international partnership aims to break down barriers and accelerate revolutionary stem cell treatments for patients worldwide.

Spryte Medical's new trial is testing a device that gives surgeons a real-time, microscopic view inside brain arteries for the first time.

PathAI's PathAssist Derm receives FDA Breakthrough designation, promising to enhance accuracy and speed in diagnosing the most common cancer in the U.S.

With its pivotal trial fully enrolled, Liberate Medical’s VentFree device aims to shorten ICU stays, reduce complications, and cut healthcare costs.

Amid a strategic overhaul, Hepion Pharmaceuticals is licensing a novel RNA-based liquid biopsy, aiming to transform early liver cancer detection.