Regulatory Approval

PMGC Holdings touts major acquisitions and a promising biotech pipeline, but a look at its financials reveals a high-stakes bet on future growth.

With a fortified balance sheet and promising clinical data, Monopar Therapeutics is advancing its lead drug, ALXN1840, toward a pivotal NDA filing.

After its pivotal trial for ersodetug missed its primary endpoint, Rezolute gets a rare nod from the FDA to submit full data, igniting new hope.

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?