FDA Approval

Mwyngil Therapeutics starts clinical trials for a novel brain-penetrating drug, aiming to tackle neuroinflammation at its source in MS and Parkinson's.

The Spanish biotech firm strengthens its IP for a novel aggression treatment, targeting a growing multi-billion dollar Japanese CNS market.

Early clinical results for MP0712, a novel Radio-DARPin, suggest a breakthrough for targeting aggressive cancers like SCLC while sparing healthy tissue.

Promising Phase 2 data for a potential first-in-class neuropathic corneal pain therapy to be showcased, offering new hope for a debilitating condition.

Incyte's Zynyz gets a key EU panel's nod, offering a breakthrough for advanced anal canal cancer patients after decades of limited treatment options.

After Amgen steps back, Kyowa Kirin takes full control of its promising atopic dermatitis drug, rocatinlimab, betting on its unique science.

Following the departure of its R&D head, Immunocore streamlines leadership, betting on internal experts to drive its next wave of innovative therapies.

Quetzal Therapeutics’ oral capsule for a rare leukemia could replace grueling IVs. The FDA's Fast Track status signals a major shift for patients and investors.

A German biotech's novel oral drug for herpes is moving to Phase 2 trials, offering new hope against a widespread and often resistant virus.

An oral drug for Huntington's disease shows early success, improving patient scores where a decline was expected, fueling hope for a breakthrough treatment.

A pivotal FDA meeting moves a novel drug forward for Dementia with Lewy Bodies, a disease with no approved therapies, offering new hope to patients.

A new drug targeting a genetic form of Parkinson's shows promise as its late-stage trial nears completion, offering hope for a precision treatment.

New research provides the strongest human evidence that sleep actively clears toxic proteins linked to Alzheimer's, opening a new frontier for prevention.

With drug pipelines facing staggering failure rates, HKeyBio's new preclinical strategy aims to de-risk R&D and accelerate effective new treatments.

A new study reveals albumin, the most abundant protein in blood, is a powerful weapon against mucormycosis, offering new hope for treating this fatal infection.

A first-in-class oral therapy targeting cellular metabolism has entered patient trials, offering new hope for a disease-modifying treatment for eczema.

A new external bioengineered liver has passed a crucial safety trial, offering a potential lifeline for patients with acute liver failure.

A single patient with a debilitating eye pain condition gains access to an investigational therapy, offering hope where no approved treatments exist.

New 24-month data suggests a novel drug could improve kidney function and reduce side effects for transplant patients, challenging a decades-old standard.

Swedish biotech innovator Hansa Biopharma wins a top award for its life-saving transplant tech, facing a pivotal year with FDA review on the horizon.