Drug Development

With ophthalmic trial failure rates soaring, a new CRO-led advisory model aims to replace academic vanity boards with operational reality.

Marathon Fusion proposes a novel supply chain hack using a stable precursor to solve the multi-decade shortage of a promising cancer-treating radioisotope.

Applying advanced pharmacokinetic simulations, Luye Pharma is challenging a $2.9 billion market by proposing flexible dosing strategies for its antipsychotic ERZOFRI.

A €12M Series A for German biotech ViferaXS highlights a strategic shift in European sovereign funding and the rise of the tech-bio equity playbook.

Crystalys Therapeutics names Tim Walbert as Chairman, signaling a bold commercial push for its de-risked gout therapy dotinurad as it enters Phase 3 trials.

Ophirex's Phase 2 trial missed its primary goals, but subgroup data and a rare FDA pathway could salvage a game-changing oral snakebite treatment.

As Recludix readies for the Oppenheimer showcase, its Sanofi-partnered STAT6 inhibitor signals a structural shift from biologics to oral small molecules.

Kedrion Biopharma secures Orphan Drug Designation for QIVIGY in Stiff Person Syndrome, leveraging regulatory incentives to build a commercial moat.

By leveraging deuterated chemistry, Aviva Bio aims to bypass the oncologic risks that have stalled FDA approval for female testosterone therapies for decades.

With standard-of-care avacopan facing global regulatory withdrawal, InflaRx is stepping into the void. A strategic look at the upcoming Capital Markets Day and the mechanics of clinical resilience.

As diabetic amputations rise globally, a micro-cap biotech enters Phase 2a trials with a novel topical gel designed to physically destroy drug-resistant superbugs.

As the biosimilar wave hits rare diseases, Sandoz and mAbxience join forces to develop a complex bispecific alternative to Roche's $5.7B blockbuster Hemlibra.

Sempresto just cleared a key FDA hurdle for its phone-mounted auto-injector. But can attaching life-saving drugs to consumer tech disrupt the allergy market?

Matisse Pharmaceuticals secures €14 million to advance a radically different approach to sepsis, targeting cytotoxic histones to stop organ failure.

Heavy menstrual bleeding drives 600,000 surgeries a year. Hemab Therapeutics aims to replace invasive treatments with a once-a-month injection.

Fennec Pharmaceuticals unveils compelling trial data showing its therapy prevents permanent hearing loss in children undergoing life-saving chemotherapy.

Kathleen Cook explores how Axsome Therapeutics uses real-world data and novel therapies to solve the hardest problems in modern psychiatric and neurologic care.

SK Biopharmaceuticals and 1ST Biotherapeutics forge a $314.8M alliance to advance a novel dual-inhibitor, reshaping the global Parkinson's landscape.

The strategic alliance between ProBio and Kun Tuo signals a shift in how global biopharma navigates the fragmented cell and gene therapy clinical landscape.

For 30 years, hair loss treatments have been trapped in a hormonal stalemate. Rubedo Life Sciences is betting its AI-driven senolytic platform can change that.