Drug Application

With positive Phase 3 data and an FDA review underway, a novel copper IUD aims to double its lifespan while navigating strict new provider safety mandates.

Biotech challengers are leveraging gene therapy and oral molecules to dismantle the legacy infusion model in the $1.7 billion Fabry disease market.

PolyPid has regained European rights to its promising infection-fighting drug. Now begins a high-stakes race to secure a partner before approval.

Invivyd's VYD2311 beats mRNA vaccines on tolerability and boosts immunity, but regulatory and economic hurdles loom large for the novel therapy.

PMV Pharma's rezatapopt shows remarkable results for a tough cancer by reactivating a key defense. A deep dive into the science, finances, and patient hope.

Inhibrx Biosciences lands a massive new loan to fuel its promising cancer drug trials, but rising costs and a wider net loss paint a high-stakes picture.

Two years after a landmark rejection, the bid to approve MDMA-assisted therapy for PTSD is back. This is more than a resubmission; it's a test case for a new paradigm in medicine.

With a Q3 FDA submission for its novel epilepsy drug azetukalner imminent, Xenon leverages a massive cash runway to expand into neuropsychiatry and pain.

With spending up and losses widening, CG Oncology is leveraging its $1B cash reserve to push its promising bladder cancer drug toward a Q4 FDA submission.

Compass Pathways is racing towards a 2027 launch for its psilocybin therapy. But can it navigate the complex regulatory and commercial hurdles to deliver on its promise?

IDEAYA Biosciences advances its breakthrough melanoma drug toward FDA review while its $1.24B cash runway fuels a deep pipeline targeting cancer's toughest codes.

Ascletis Pharma announces a new once-daily oral obesity drug, aiming to match the power of injectables like Zepbound in a convenient pill form.

Foresee Pharmaceuticals signals a major shift to commercialization, appointing Brian J. Groch to lead the launch of its 6-month CPP treatment, FP-001.

Galderma's innovative neuromodulator, a key to its 'powerhouse' ambitions, hits a U.S. roadblock. The FDA's concerns? Manufacturing, not safety.

In a head-to-head battle, Takeda's zasocitinib showed superior skin clearance over a key competitor, signaling a potential new standard for oral therapy.

For years, CIDP patients faced limited options. Now, a wave of targeted therapies promises to transform treatment, sparking a multi-billion dollar market boom.

As a rare Ebola strain rages in a DRC warzone, the G7 pledges massive aid. But with fragile peace deals and no proven cure, is it enough to stop a global crisis?

A new partnership between Biocartis and City of Hope seeks to transform pancreatic cancer outcomes by pairing breakthrough biomarkers with rapid diagnostic technology.

Vanda Pharmaceuticals' rare disease drug gets a key designation in Japan, unlocking major incentives and promising a new treatment for a severe skin disease.

MBX Biosciences prepares for the Jefferies conference, with investors eyeing updates on its late-stage hypoparathyroidism drug and promising obesity portfolio.