FDA's Unprecedented Rejection of Moderna's mRNA Flu Vaccine Sends Shockwaves Through Biotech Industry

The FDA's unprecedented rejection of Moderna's mRNA flu vaccine application marks a dramatic departure from traditional regulatory practices and raises profound questions about the future of vaccine innovation in America.

HanchorBio Achieves FDA Breakthrough: First SIRPα-IgG4 Fc Fusion Protein Granted Orphan Status for Gastric Cancer

Taiwan-based HanchorBio announced FDA Orphan Drug Designation for HCB101, marking the first recognition of a SIRPα-IgG4 Fc fusion protein in gastric cancer treatment.

ErlySign Achieves FDA Breakthrough: Revolutionary Saliva Test Could Transform Oral Cancer Detection

Nagpur-based ErlySign receives FDA Breakthrough Device Designation for its innovative saliva-based oral cancer detection kit, marking a significant milestone in non-invasive cancer diagnostics.

Roche's Fenebrutinib Emerges as Potential Breakthrough in Primary Progressive Multiple Sclerosis

In a landmark development that could transform treatment for one of neurology's most challenging conditions, Swiss pharmaceutical giant Roche has unveiled late-breaking Phase III data showing its investigational oral therapy fenebrutinib significantly slowed disability progression in people with primary progressive multiple sclerosis (PPMS). The results position fenebrutinib as

Eli Lilly Makes Bold $2.4 Billion Bet on Revolutionary In Vivo CAR-T Technology with Orna Therapeutics Acquisition

Eli Lilly's $2.4 billion acquisition of Orna Therapeutics marks a transformative entry into in vivo CAR-T therapy, leveraging revolutionary circular RNA technology to democratize cell therapy for autoimmune diseases.

REGENXBIO Faces Critical Setback as FDA Halts Gene Therapy Trials Following Pediatric Brain Tumor Discovery

REGENXBIO announced that the FDA has placed clinical holds on RGX-111 and RGX-121 following the discovery of a brain tumor in a pediatric patient treated with gene therapy, raising critical questions about AAV vector safety.

Affinia Therapeutics Breaks New Ground: FDA Clears First Gene Therapy Trial for Rare Heart Disease

In a significant regulatory milestone that could transform treatment for one of cardiology's most challenging genetic conditions, Affinia Therapeutics announced on February 5, 2026, that the FDA has cleared its Investigational New Drug (IND) application for AFTX-201, marking a pivotal moment in the development of gene therapies for

Hanmi Pharmaceutical Achieves FDA Breakthrough Designation for Revolutionary Rare Disease Treatment

In a significant regulatory milestone that could transform treatment for one of medicine's most challenging rare diseases, South Korea-based Hanmi Pharmaceutical announced on February 5, 2026, that the FDA has granted Breakthrough Therapy Designation to efpeglucagon (HM15136) for treating congenital hyperinsulinism (CHI). This designation positions the investigational therapy

After BMS’s $850M Bet on Tumor-Activated Immunotherapy, Investors Are Asking: Who’s Next?

Bristol Myers Squibb’s $850M Janux deal highlights growing pharma interest in tumor-activated immunotherapy. Purple Biotech is an under-the-radar player advancing a conditionally activated, multi-mechanism approach aligned with this emerging shift in solid tumor treatment.

Micoy Therapeutics Achieves FDA Breakthrough Designation for Revolutionary Point-of-Care Test Targeting Folate Deficiency

In a significant regulatory milestone that could transform diagnostic testing for a critical nutritional deficiency, Brooklyn-based Micoy Therapeutics announced on January 12, 2026, that the FDA has granted Breakthrough Device Designation to its NeuroLume™ Test. This innovative point-of-care diagnostic represents the first FDA-recognized test specifically designed to detect folate receptor

Biogen Achieves Regulatory Milestone as FDA Grants Breakthrough Status to First-in-Class Lupus Therapy

In a significant regulatory achievement that could transform treatment for millions of Americans living with a debilitating autoimmune skin condition, Biogen announced on January 28, 2026, that the FDA has granted Breakthrough Therapy Designation to litifilimab (BIIB059) for treating cutaneous lupus erythematosus (CLE). This milestone positions the investigational therapy as

Adolore BioTherapeutics Breaks New Ground: FDA Grants Orphan Drug Status for Revolutionary Gene Therapy Targeting Rare Pain Disorder

Florida-based Adolore BioTherapeutics announced that the FDA has granted Orphan Drug Designation to its innovative rdHSV-CA8* gene therapy for treating erythromelalgia, positioning the company at the forefront of a revolutionary approach to chronic pain management.