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On February 26, 2026, the Food and Drug Administration granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for an expanded indication […]

Image By: Barclay Butler, Ph.D., Deputy Commissioner for Operations and Chief Operating Officer When Americans look to the U.S. Food and Drug Administration, they are expecting […]

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 […]