The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A.

The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 7/28/2026 Short Title (70 char) Apollo Care LLC. Columbia, MO. 483 issued 7/28/2026 FEI Number 3013927023 Firm Name Apollo Care LLC Record Type 483 State MO Establishment Type 503B Outsourcing Facility

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 7/10/2026 Short Title (70 char) Brookfield Medical Surgical Supplies Inc. Brookfield, CT. 483 issued 7/10/2026 FEI Number 3011430551 Firm Name Brookfield Medical Surgical Supplies Inc Record Type 483 State CT Es

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 7/31/2026 Short Title (70 char) CD Pharmacy LLC dba Red Rock Pharmacy. Springville, UT. 483 issued 07/31/2026 FEI Number 3032406608 Firm Name CD Pharmacy LLC dba Red Rock Pharmacy Record Type 483 State UT Establ

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 6/17/2026 Short Title (70 char) XeCare LLC. New Albany, OH. 483 issued 6/17/2026 FEI Number 3017865039 Firm Name XeCare LLC Record Type 483 State OH Establishment Type Producer of Sterile & Non-Sterile Drug Prod

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 5/07/2026 Short Title (70 char) Turbare Manufacturing. Conway, AR. 483 issued 5/07/2026 FEI Number 3027507354 Firm Name Turbare Manufacturing Record Type 483 State AR Establishment Type Outsourcing Facility

The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN)

The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.

The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 6/15/2026 Short Title (70 char) Fayetteville VA Medical Center. Fayetteville, NC. 483 issued 6/15/2026 FEI Number 1073803 Firm Name Fayetteville VA Medical Center Record Type 483 State NC Establishment Type Prod

The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar

The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.

The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.

The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.

FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.

The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.

The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.

The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa)

The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.