Tag: FDA

U.S Food and Drug Administration (FDA)

Kidney Patients Push for Policy Changes During Congressional Recess

Kidney patients and organ donors are urging US lawmakers to advance policies…

ME Desk

U.S. FDA Approves XFG-Adapted COVID-19 Vaccine for 2026–2027

U.S. FDA approves the XFG-adapted 2026–2027 COVID-19 vaccine from Pfizer and BioNTech…

ME Desk

FDA Clears Blood Test to Support Alzheimer’s Disease Assessment

The FDA has cleared a pTau217 blood test to support Alzheimer’s disease…

ME Desk

FDA Authorizes Robotic Device for Automated Blood Collection

FDA authorizes Vitestro’s Aletta, a robotic blood-drawing device designed to automate blood…

ME Desk

Emergency Authorization Expands Treatment Options for New World Screwworm in Dogs

FDA grants emergency authorization for Simparica Trio to treat New World screwworm…

ME Desk

FDA Grants Breakthrough Therapy Designation to Olomorasib for Advanced Pancreatic Cancer

The U.S. FDA has granted Breakthrough Therapy designation to Lilly's investigational KRAS…

ME Desk

Major Acquisition to Advance Therapies for Treatment-Resistant Depression

Lilly will acquire AtaiBeckley in a deal valued at up to $3.8…

ME Desk

ADAP Crisis Task Force Strikes Deal to Widen Access to New HIV Pill

Merck has partnered with the ADAP Crisis Task Force to expand access…

ME Desk

Harbour BioMed Announces NMPA Acceptance for the Treatment of Advanced Solid Tumors

Harbour BioMed has announced that China’s National Medical Products Administration (NMPA) has…

ME Desk

ImmunityBio Signs Exclusive U.S. Agreement with Japan BCG Laboratory to Expand BCG Supply in the United States

ImmunityBio has signed an exclusive U.S. development and supply agreement with Japan…

ME Desk