Regulatory Approval

With major drug approvals on the horizon, Nuvalent's leadership will detail its strategy for its next-gen cancer therapies at an influential investor summit.

Everest Medicines bets big on MT1013, a novel dual-action drug poised to transform treatment for millions with chronic kidney disease complications.

iVeena promotes key execs as it prepares for clinical trials of a novel eye drop that could reshape pediatric myopia treatment worldwide.

The digital health giant now offers a 50+ cancer blood test, promising early detection. But experts caution on its limits and lack of FDA approval.

CoSara Diagnostics' ISO 13485 certification paves the way for regulatory approval of a new PCR platform, leveraging India's 'Make in India' initiative.

Acarix's CADScor®System gains stringent EU MDR certification, a move poised to reshape cardiac diagnostics and fuel the company's expansion in the U.S.

An expanded partnership aims to deliver a once-daily oral tablet for hypoparathyroidism, potentially revolutionizing treatment for thousands of patients.

A new biotech partnership is accelerating development of a once-daily tablet for hypoparathyroidism, a rare disease currently requiring injections.

Celcuity prepares for a key fireside chat at Guggenheim's 2026 summit, with investors eyeing crucial updates on its lead cancer drug, gedatolisib.

The Bozeman tech firm saw record growth as the energy sector embraces its advanced LiDAR for methane detection and navigating complex global regulations.

As the FDA embraces advanced Bayesian statistics, MedTech firm BioStem sees validation for its wound care research, promising faster innovation for patients.

Following promising early results, RESTEM's Restem-L cell therapy enters a pivotal Phase 2/3 trial, aiming to transform treatment for IIM patients.

The tire giant's latest deal for a sealing specialist signals an aggressive push into high-value materials, moving far beyond its rubber-and-road legacy.

Regulators deem PRRS-resistant pigs safe, promising a future with less animal disease and antibiotic use, but sparking debate on consumer transparency.

With a key drug for a rare disease nearing the finish line, Spruce adds two industry veterans to navigate the high-stakes FDA approval process.

Relay Therapeutics' experimental drug, zovegalisib, offers new hope for a common and hard-to-treat form of advanced breast cancer with a promising safety profile.

Promega's new diagnostic for KEYTRUDA gains NMPA approval, opening doors for targeted solid tumor therapy amid China's growing precision medicine market.

Amid a relentless outbreak, Brazil launches a massive pilot program for the IXCHIQ® vaccine, a critical test for public health and global preparedness.

Pharming Group projects strong 2026 growth, fueling ambitious clinical programs for rare immunodeficiencies and mitochondrial diseases.

NurExone appoints Eyal Gabbai, a healthcare and finance heavyweight, to its board, signaling a strategic pivot from R&D to market execution for its therapies.