R3 Vascular Inc., a medical device company focused on developing bioresorbable scaffolds for peripheral arterial disease (PAD), has announced the completion of an $87 million Series B financing round. The funding, led by Deerfield Management, will support the ELITE FDA IDE pivotal trial of its MAGNITUDE® bioresorbable scaffold for below-the-knee PAD, alongside R&D, regulatory submissions, and manufacturing scale-up. Christopher M. Owens has been appointed as the new President and CEO, bringing over three decades of medical device industry experience to the role.

Iker Huerga, former Chief Data Scientist for Oncology R&D at AstraZeneca, has been appointed as CEO of Pathos AI to lead the company's AI-enabled oncology drug development platform.

Nuvalent is preparing to submit its first New Drug Application by mid-2025 for zidesamtinib in TKI pre-treated ROS1-positive NSCLC, with pivotal data expected in the first half of 2025.

Sagimet Biosciences' denifanstat receives Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis.

Singapore-based ACM Biolabs receives $2.87 million from CEPI to develop their thermostable mRNA delivery technology that enables vaccine storage at 2-8°C instead of ultra-low temperatures.

BrightHeart's B-Right Views has received FDA 510(k) clearance, marking the company's third regulatory approval for AI-powered fetal heart ultrasound assessment technology.

• BioMx completed patient enrollment for its Phase 2 trial of BX201 for Diabetic Foot Osteomyelitis (DFO), with topline results expected in Q1 2025. • Manufacturing delays for BX004, a phage cocktail for cystic fibrosis, have shifted the expected topline results to the first half of 2026. • Positive safety and efficacy data from the BX004 Phase 1b/2a trial were presented at major scientific conferences, reinforcing confidence in the program. • The company's cash reserves are projected to fund operations into the fourth quarter of 2025, supporting continued clinical development.

Allogene Therapeutics is restructuring its pipeline to focus on four allogeneic CAR-T assets, cutting 22% of its workforce to extend financial runway into 2026.

The FDA has accepted Ionis Pharmaceuticals' NDA for olezarsen with Priority Review for treating adults with familial chylomicronemia syndrome (FCS).

UroGen Pharma has submitted an NDA to the FDA for UGN-102 (mitomycin) for intravesical solution for treating low-grade, intermediate-risk NMIBC.

Kincell Bio has completed a $22 million funding round led by NewSpring Capital and Kineticos Life Sciences to accelerate its cGMP capabilities and process development services for cell therapies.

Vertex Pharmaceuticals reported Q1 2025 revenue of $2.77 billion, representing a 3% year-over-year increase, driven by successful launches of ALYFTREK and CASGEVY.

The FDA and HHS have initiated 'Operation Stork Speed,' the first comprehensive review of infant formula nutritional standards since 1998, seeking public input through September 2025.

Novo Nordisk's semaglutide (Wegovy) demonstrated statistically significant improvement in liver fibrosis and resolution of steatohepatitis in a Phase III trial compared to placebo.

The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer, representing a significant breakthrough after years of development and regulatory challenges.

The UK has made a landmark decision to approve the world's first CRISPR-based gene therapy, developed by Vertex Pharmaceuticals, for treating sickle cell disease and β-thalassemia.

Intellia Therapeutics' NTLA-2001 demonstrates potential in stabilizing or improving outcomes for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) patients.

Phesi's analysis of 167 million patient records reveals colorectal cancer has the largest volume of real-world data with nearly six million records, outpacing breast, lung, liver, and prostate cancers.

A phase I study of OTX-TKI, an intravitreal implant containing axitinib, demonstrated a significant reduction in injection frequency for wet AMD patients.

The FDA has added warnings about myocarditis and pericarditis risks to Moderna and Pfizer-BioNTech COVID-19 vaccine fact sheets following reports of heart inflammation, particularly after second doses.