The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic […]

On February 24, 2026, the Food and Drug Administration granted traditional approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) in combination with […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Daniel D. Hernandez Recipient Title Director of Quality MedisourceRx 10525 Humbolt StreetLos Alamitos, CA 90720-5401United States […]

Delivery Method: VIA UPS Reference #: 320-26-45 Product: Drugs Recipient: Recipient Name Mr. Marc N. Ross Recipient Title Quality Manager/Co-Owner AQ USA Inc., d.b.a Ross Healthcare […]

Delivery Method: VIA UPS Reference #: 320-26-46 Product: Drugs Recipient: Recipient Name Michael Lockett Recipient Title Chief Executive Officer A. Nelson & Co. Ltd. 83 ParksideLondonSW19 […]

In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only […]

On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA). This new law includes the reauthorization of the Prescription […]

Save the Date Agenda Coming Soon Register Here Visit CDER Small Business and Industry Assistance (SBIA) Homepage About this Event (Hosted by CDER SBIA) The annual […]

On February 19, 2026, the Food and Drug Administration approved acalabrutinib (Calquence, AstraZeneca) tablets and capsules in combination with venetoclax (Venclexta, AbbVie Inc. and Genentech Inc.) […]