Regulatory Approval

A Belgian firm's new biologic gel for diabetic foot ulcers gets a key FDA green light, offering hope against a leading cause of amputations.

A new fluid that eliminates ultrasound 'noise' during brain tumor removal could give surgeons a clearer view, promising better outcomes for patients.

As its oesophageal cancer vaccine enters trials, Infinitopes hires a top CSO with a track record of bringing breakthrough therapies to market.

A new partnership leverages an FDA-designated analytics platform to solve critical AAV manufacturing hurdles, promising safer, more reliable gene therapies.

A renewed alliance aims to break key supply chain bottlenecks in gene therapy, offering developers faster access to critical, regulatory-ready materials.

An innovative RNA-editing therapy for hepatocellular carcinoma has received a major FDA designation, potentially accelerating its path to patients.

A lifetime achievement award recognizes Melissa Kennedy's pivotal role in legal strategy, diversity, and mentorship, defining the modern in-house counsel.

A new health campaign uses emotional appeals to boost adult vaccination in Southeast Asia, highlighting the complex role of pharma in public health.

Taimei Technology and C&R Research forge a strategic alliance, deploying advanced AI to automate and accelerate drug development in Asia's key research hub.

ABEC's expanded group integrates advanced modeling and custom engineering to accelerate drug development, reduce risk, and boost manufacturing efficiency.

With a key FDA decision looming, Cristcot hires Rayna Herman to lead the commercial strategy for its first-in-class ulcerative colitis therapy, ngHCA.

Central Florida's first new community bank in a decade, Portrait Bank, combines a powerhouse board with AI tech to challenge the region's financial giants.

A new all-in-one system from Sweden's Multi4 Medical just won EU approval, allowing urologists to treat bladder cancer in minutes without surgery.

A new FDA-cleared shoulder implant from FX Shoulder Solutions offers unprecedented flexibility, allowing surgeons to adapt their approach mid-surgery.

A new biotech emerges with a promising, late-stage gene therapy for Sanfilippo syndrome, offering a potential lifeline for children with no other options.

neurocare's TMS device approval marks a major shift in the Kingdom's approach to depression, prioritizing non-invasive, tech-driven solutions.

The new Gibco CTS DynaXS bioreactor aims to unlock scalable production, making life-saving cell therapies more accessible and affordable for patients.

The clinical-stage biotech adds seasoned veterans from Eli Lilly and Iovance to accelerate its promising DNA Damage Response pipeline toward commercialization.

Valitor's VLTR-559 shows superior durability in preclinical data, potentially slashing wet AMD treatment from monthly injections to just two per year.

A devastating infant liver disorder meets a potential breakthrough. Satellite Bio's novel cell therapy just received a critical FDA nod, paving the way for trials.