Regulatory Approval

Vexev’s AI-powered robotic ultrasound platform just raised $6M to tackle the specialist shortage and transform cardiovascular disease diagnostics for millions.

A new Health Canada approval for Regeneron's Libtayo offers a breakthrough for high-risk skin cancer patients and a strategic win for the company.

A startup led by ex-Novo Nordisk execs plans a reverse takeover to fund its made-in-Canada generic Ozempic, aiming to disrupt a C$3.5B market.

With the launch of its TED drug Lumvoa, Viridian Therapeutics steps into the commercial ring. But can early momentum and a deep pipeline justify the cost?

Priovant's Phase 3 trial for brepocitinib in cutaneous sarcoidosis isn't just about one disease. It's a key move in Roivant's playbook to build a rare disease powerhouse.

GRAIL’s Galleri test shows stunning clinical results and sales growth, but staggering financial losses and a looming FDA review create a high-wire act for innovation.

A revenue dip masks a calculated pivot. UTHR is betting its future not just on new drugs, but on a revolutionary plan to manufacture human organs.

Submission of a critical design report to Idaho regulators moves the Black Pine gold project closer to reality, testing the balance of profit and protection.

With the Federal Reserve's final nod, Santander's $12.3B acquisition of Webster is set. What does this mega-merger signal for U.S. banking competition?

Immix Biopharma heads to Morgan Stanley's key conference. Can its promising CAR-T therapy for AL Amyloidosis convince investors to fund the final mile?

Healis Therapeutics gets FDA nod for Tyemvers, a botulinum toxin therapy for depression. Can a drug that paralyzes frown muscles disrupt mental healthcare?

A landmark study on Haemonetics' VASCADE MVP XL system proves it enables same-day discharge for complex heart procedures, a win for patients and hospitals.

A pivotal CMS ruling grants Carlsmed's AI-driven spinal implants a dedicated payment code, unlocking market access and signaling a new era for med-tech.

Biocon's Yesafili, an interchangeable biosimilar to the $5.9B eye drug Eylea, launches in the US, promising major cost savings and market disruption.

The FDA has fast-tracked a novel peanut allergy therapy from Aravax, signaling a major shift in the multi-billion dollar race to find a lasting solution.

The creation of an offshore energy titan moves one step closer with US antitrust approval, but a deeper probe in Europe will decide its ultimate fate.

Circle just secured a coveted New York trust charter, creating a 'state-federal compliance stack' for USDC. Here's why this is a game-changer.

While Washington State champions farmworker housing, a key agency is accused of blocking it. Are bureaucratic hurdles or deeper issues stalling progress?

TXNM Energy's impressive Q2 earnings are overshadowed by a delayed Blackstone acquisition and the urgent, costly need to modernize its grid for a renewable future.

DeepHealth's newly FDA-cleared AI for breast ultrasound promises to standardize a complex exam, boost accuracy, and reduce radiologist workload.