FDA Approval

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.

With promising brain scan data, a deep therapeutic pipeline, and a cash runway into 2027, Radiopharm Theranostics is gaining significant momentum.

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.

A new COVID-19 drug targets patients who can't take Paxlovid, while a once-a-month pill could revolutionize how we prevent seasonal influenza.

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

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.

BioAge Labs is developing an oral drug for diabetic macular edema, a breakthrough that could end the need for frequent, invasive eye injections for millions.

Genmab's antibody drug epcoritamab is the first of its kind to slow cancer progression in a Phase 3 trial for R/R DLBCL, offering a new path for patients.

A sudden collapse led to a rare cancer diagnosis for a NJ teen. His story of recovery highlights a therapy that targets tumors while sparing young minds.

Promising new 96-week data shows Vir's therapy could redefine care for severe hepatitis delta, as its oncology pipeline and financial runway also advance.

Biotech firm Bright Minds Biosciences closes a massive $175M deal, fueling its race to develop novel drugs for epilepsy and rare neurological conditions.

With a key FDA decision looming, Orca Bio's massive new funding aims to commercialize a therapy that could make curative transplants safer for more patients.

A new study reveals the hidden quality-of-life toll of a common virus on transplant patients, highlighting the urgent need for targeted new therapies.

New research reveals a stark disconnect between clinical views and patient reality in atopic dermatitis, with millions suffering severe, overlooked impacts.

A new class of painkillers promises the power of opioids with a far lower risk of addiction. Tris Pharma's cebranopadol could reshape pain management.

NeuroSense adds world-renowned expert Prof. Steven Arnold to its board, a major vote of confidence in its multi-target Alzheimer's drug, PrimeC.

With multiple clinical trials advancing and a savvy global expansion, RESTEM is poised to challenge the treatment paradigm for autoimmune disorders.

A first-in-class antibody shows a strong safety profile, de-risking development and offering a new, targeted approach for severe autoimmune diseases.