Regulatory Approval

As Olin and Huntsman clear a key SEC hurdle, the strategic rationale behind their merger comes into focus: a calculated move to build a resilient, vertically integrated powerhouse.

Atrium Therapeutics' clinical trial for a rare cardiomyopathy isn't just a milestone; it's a strategic maneuver signaling the arrival of precision RNA therapies in cardiology.

With ASTM approval secured and mandates looming, Argus Media's new methanol-to-jet index provides the pricing transparency needed to fuel aviation's costly green transition.

Milla Pharmaceuticals' new FDA approval for a vital acidosis drug offers hope for hospitals battling chronic shortages and marks a key strategic win for parent A.forall.

Voyager Therapeutics' new gene therapy just cleared a key FDA hurdle. With promising preclinical data, it's a major momentum signal in the fight against Alzheimer's.

After an initial rejection, Sydnexis's pediatric myopia drug gets a crucial FDA hearing, raising hopes for the first approved U.S. pharmaceutical treatment.

With its new FDA-cleared Osia 3, Cochlear isn't just launching a rechargeable device. It's executing a strategic overhaul of the user experience and service delivery.

Amid key technical wins like piloted transition, Vertical Aerospace delays its eVTOL certification, a move reflecting an industry-wide reality check.

After securing a key federal permit, Cadiz Inc. is poised to build its desert water pipeline. But behind the promise of relief lies a history of controversy.

A new FDA-cleared robotic system from ZETA SURGICAL promises to deliver mental health therapy with surgical precision, potentially revolutionizing access for millions.

As Europe's MiCAR deadline culls 83% of crypto firms, Hong Kong-licensed OSL Group secures Austrian approval, positioning it as a top regulated player.

With a landmark NEJM publication and FDA approval, Rhythm Pharma's setmelanotide offers hope for a rare obesity, proving a potent strategy for niche markets.

Vantage Markets' new UAE licence isn't just a regulatory win; it's a signal of a broader shift. We decode what it means for the firm, its rivals, and traders.

A new collagen implant is changing ACL treatment, enabling the body to heal itself and significantly reducing the long-term risk of knee osteoarthritis.

Valid8 Financial's move toward FedRAMP certification signals a major shift in how government agencies tackle financial crime. Here's why it matters.

With a PDUFA date set, Arcutis' ZORYVE could soon offer a once-daily, non-steroidal cream for infants, addressing a massive unmet need for families.

With bladder cancer recurrence rates stubbornly high, UroGen Pharma is advancing a novel oncolytic virus into human trials. Can it finally break the cycle?

Presage Technologies' new FDA-cleared app turns any phone into a vital signs monitor, offering it free to hospitals to democratize healthcare access.

Saol Therapeutics' NDA resubmission isn't just a second chance; it's a calculated maneuver signaling a new playbook for navigating the FDA in rare disease.

The FDA has fast-tracked mitapivat for sickle cell disease, offering new hope for patients. But a closer look reveals the high stakes of this strategy.