Regulatory Approval

A federal court sided with Vitti Labs, ruling the FDA's interpretation of tissue rules "plainly erroneous." The decision could reshape the entire industry.

FDA greenlights a novel, AI-discovered therapy for a Phase 1 trial, offering new hope for children with devastating central nervous system tumors.

Amid a major leadership change, Sonorous Neurovascular pushes its pioneering BosSTENT™ for pulsatile tinnitus sufferers closer to market approval.

Agenus prepares a crucial update on its BOT+BAL immunotherapy, a potential breakthrough for cancers resistant to current treatments. What will they reveal?

INNOVATE Corp. reports a 62% Q4 revenue surge, but a 'going concern' warning and looming debt have forced the company to explore selling key assets.

Crinetics Pharmaceuticals aims to disrupt Brazil's acromegaly treatment with Palsonify, a once-daily pill challenging the standard of monthly injections.

With critical data due in 2026 and a leaner financial strategy, Zentalis is advancing its targeted therapy for a hard-to-treat ovarian cancer.

A promising oral therapy for a rare, aggressive lung cancer is now under review in Europe, offering a new option for patients with limited treatments.

Eurofins Viracor's new assay delivers rapid insights into CAR T-cell performance, promising faster, more personalized decisions for cancer patients.

A key recommendation for the drug BIMZELX could soon give Quebec patients a powerful new weapon against the debilitating skin disease hidradenitis suppurativa.

The company's B-cell cancer assay has achieved stringent IVDR certification, navigating a complex landscape and gaining a key edge in Europe's market.

Armata Pharmaceuticals posts a staggering $174M annual loss, triggering a 'going concern' alert, yet its promising phage therapy pipeline advances.

Investview rebrands its controversial iGenius platform to Conectiv, adding wellness. But can a new name escape a history of regulatory fines and pyramid scheme allegations?

A Texas medtech firm ranked 45th on Fortune's innovation list, challenging giants with a powerful R&D strategy and new hope for chronic pain sufferers.

The FDA has clarified its rules for desiccated thyroid extract (DTE), providing relief for patients and a new path forward for manufacturers like Acella.

Early data for VG801 shows vision improvement in Stargardt disease patients, leveraging novel tech and fast-track FDA support to tackle a leading cause of blindness.

Riding high on record 2025 results and a new FDA approval, LivaNova faces intense scrutiny ahead of its May 6 earnings call. Can it sustain the momentum?

New data reveals Otsuka's VOYXACT clears key markers of kidney damage in IgA nephropathy, offering new hope beyond symptom management for patients.

Health Canada greenlights MeMed's rapid diagnostic tool, a major step in the nation's fight against deadly sepsis and growing antimicrobial resistance.

Biotronik launches a global study for its LivIQ system, a single-device leadless pacemaker using novel far-field sensing to restore a natural heartbeat.