FDA Approval

A new campaign by Palvella Therapeutics and key partners aims to educate and empower patients with a rare disease, a strategic move ahead of a potential new drug.

Agenus activates a key manufacturing pact with Zydus, scaling production for its promising BOT+BAL cancer therapy ahead of regulatory filings and market launch.

A new drug targeting the root cause of deadly device infections enters a pivotal trial, offering hope to millions and challenging a $20 billion problem.

Eledon's tegoprubart gets Orphan Drug status, signaling a new era for liver transplant patients by potentially replacing toxic, decades-old therapies.

After selling assets and raising cash, Q32 Bio focuses all its resources on bempikibart, a novel drug for hair loss, with pivotal data due in 2026.

A new, highly selective drug for Duchenne muscular dystrophy shows potential to be safer and more effective, targeting both muscle and heart decline.

With one trial halted and another beginning, the company focuses its cash and hopes on BBI-940, a novel drug targeting a fundamental driver of cancer.

A new non-thermal ablation technology shows long-term success in shrinking thyroid nodules with high patient satisfaction, potentially disrupting surgical norms.

Allarity Therapeutics lands a crucial $20M debt deal to push its unique ovarian cancer drug, stenoparib, through late-stage trials and extend its runway to 2028.

After its public debut, BBOT unveils exciting early data from three unique cancer drugs, including a first in pancreatic cancer, backed by a strong cash runway.

NextCure accelerates its high-stakes ovarian cancer drug trial, but with cash dwindling, can it reach the finish line before time runs out?

With a strong cash position, ArriVent pushes its lead lung cancer drug toward a mid-2026 data readout while building a new pipeline in ADCs.

The biotech firm accelerates a key trial but faces a partner loss, widening losses, and a CEO search, putting its promising siRNA pipeline at a crossroads.

Investors watch closely as CytoSorbents balances a push for profitability with high-stakes regulatory hurdles for its life-saving blood purification tech.

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

OmniAb reported declining revenue and a wider net loss for 2025, even as it launched its revolutionary OmniUltra platform and its partners' drugs advance.

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

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

After solving a key manufacturing flaw, CervoMed advances its promising dementia drug, neflamapimod, to a Phase 3 trial with an optimized dose.

Immunome announces stellar Phase 3 data for its desmoid tumor drug, varegacestat, and details a robust, well-funded ADC pipeline aimed at solid tumors.