Pharmaceuticals

KVK-Tech announced a flawless FDA inspection this week. But behind the press release lies a complex story of federal monitors and generic drug economics.

As US policies freeze out Chinese biopharma, Altruist Biologics' flawless EMA audit reveals a pragmatic Europe prioritizing patient access over politics.

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.

A third-party web vulnerability at a major mail-order pharmacy highlights the hidden supply chain risks threatening patient medical and financial data.

Novo Nordisk and Siemens Healthineers are rewriting the commercialization playbook by pairing blockbuster metabolic drugs with accessible blood diagnostics.

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.

A $450 patent error opened Canada to generic semaglutide. Now, Novo Nordisk is using supply chain supremacy to beat back competitors and reclaim the market.

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.

By pairing high fashion with complex pharmacology, Sun Pharma aims to capture a multi-billion dollar autoimmune market—but genetic testing and black-box warnings stand in the way.

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.

After decades of regulatory gridlock, a breakthrough UV filter finally hits US shelves. Here is how it could end the reign of gray-market K-beauty imports.

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

Debra Allen explores how the new integration between CCC and AVAYL is setting a blueprint for copyright-compliant, AI-driven medical workflows.

Newly independent Ennature Biopharma is betting on validated science for its botanicals, aiming to lead the booming women's health market with transparency.