Regulatory Approval

Disc Medicine's promising EPP drug hits a major roadblock as the FDA seeks more data, delaying hope for patients and setting up a high-stakes trial.

The firm reports a $195M cash reserve but a wider net loss as it nears crucial data readouts for its novel depression and anxiety drug candidates.

Finnish medtech firm Bioretec reports staggering 2025 losses but bets its future on breakthrough implant technology and a complete strategic overhaul.

After its lead anxiety drug failed a key trial, Vistagen turns to AI and a new menopause treatment to secure its future. Can the company recover?

FDA approval for new 6- and 24-count NARCAN packs aims to streamline distribution for first responders and public health groups on the front lines.

With strong Phase 1 data and key FDA backing, Trethera's TRE-515 is advancing as a 'pipeline-in-a-product' for a wide range of diseases.

Workers' compensation specialist Summit enters Delaware and Pennsylvania, promising tailored services and shaking up the market for local businesses.

Amid rising enforcement, RegTech firm Change Agents adds top compliance experts to guide firms through a complex digital finance and sanctions landscape.

With promising new data for its cancer and obesity pipeline, Corbus Pharmaceuticals prepares for a crucial investor presentation at the Oppenheimer conference.

A landmark deal in the Andaman Sea unlocks vast natural gas reserves, aiming to secure Indonesia's energy future and redefine Southeast Asia's energy map.

Entergy posts strong 2025 earnings and eyes major growth, driven by a surge in demand from data centers and massive new infrastructure projects.

New data reveals Mesoblast's cell therapy Ryoncil dramatically boosts survival in GvHD patients when used early, paving the way for a major adult trial.

As Caroline Dorsa retires, Biogen elects Dr. Maria Freire as its new chair, a strategic move placing deep scientific expertise at the helm for a critical period.

A mechanics union has secured a new contract but now faces a new battle, vowing to protect jobs and safety standards as two major airlines plan to merge.

Following key FDA progress for its oral osteoporosis drug, Entera Bio's CEO and board members are buying up company stock, signaling deep confidence.

Katherine Stueland’s honor underscores a major shift in healthcare, as genomic screening and AI promise to end the diagnostic odyssey for rare diseases.

At a key summit, Candel Therapeutics will showcase how its oncolytic virus, CAN-3110, uses biomarkers to fight one of the deadliest brain cancers.

Pharma veteran Pinder Sahota joins digital health firm Reset Health, signaling a strategic shift to integrated care in the new era of weight-loss drugs.

Zelluna partners with Medpace for a first-in-human trial of its ZIMA-101 TCR-NK therapy, a new 'off-the-shelf' approach for hard-to-treat solid tumors.

With a 135% revenue surge and a key FDA submission for its kidney transplant drug, Hansa Biopharma is poised for a pivotal year of expansion.