Regulatory Approval

Early trial data suggests GRI-0621 could be a game-changer for Idiopathic Pulmonary Fibrosis, showing lung repair and a much better safety profile.

Aardvark Therapeutics' pivotal trial for Prader-Willi syndrome goes global, a key step toward commercializing its novel hunger-suppressing drug.

Beyond a simple FDA approval, Amneal's entry into the epinephrine vial market is a calculated move to fix a broken supply chain and drive growth.

PathAI's AIM-MASH tool just got dual FDA/EMA approval, a first for AI pathology. This could slash MASH drug development time and reshape clinical trials.

Clene Inc. heads to an investor conference with powerful new ALS data. But with a limited cash runway, the real test is securing market confidence.

AskBio's gene therapies for Parkinson's and heart failure have received Japan's SAKIGAKE designation, promising a faster path to patients.

A new lab system combines speed, multiplexing, and regulatory trust, promising to accelerate drug development and deepen our biological understanding.

For those with severe PTSD and depression, hope is scarce. Biotech firm Compass Pathways is pioneering a psilocybin treatment that could change everything.

Imviva Biotech's 'off-the-shelf' cell therapies could make life-saving treatments faster and more accessible. But what does this mean for patients?

FDA clears Phase IIb trial for CS1, an epigenetic drug aiming to reverse PAH damage, not just manage symptoms, signaling a major market and patient shift.

Imviva Biotech's 'ready-to-use' CAR-T therapy shows breakthrough results, offering new hope and eliminating life-threatening waits for leukemia patients.

New clinical data reveals a breakthrough 'off-the-shelf' cell therapy that could treat severe autoimmune diseases by re-engineering cellular identity.

A Houston biotech reports a 100% response rate with its new CAR-T therapy, offering a potential lifeline for patients with a devastatingly rare cancer.

A South Korean biotech's novel antibody, now named rapaprutug, could shift the paradigm for pulmonary arterial hypertension by targeting its root causes.

EyeYon Medical's synthetic corneal implant, EndoArt, just got FDA approval for U.S. trials, offering a fix for the global donor tissue shortage.

A new 31-strain vaccine enters final trials, threatening to upend the market and offer unprecedented protection against a persistent bacterial threat.

Seegene expands to France's lucrative diagnostics market, but the real story is its plan to build an automated, data-driven health intelligence network.

New clinical data on VALTOCO nasal spray shows significant benefits for young children, reinforcing the critical need for rapid seizure intervention.

A regulatory filing shows hedge fund Balyasny's active trading in Avadel Pharma, exposing a merger arbitrage strategy amid a fierce bidding war.