Dabur India Limited - 01/16/2026. Country: India. Record Type: 483

Intas Pharmaceutical Limited - 09/17/2025. Country: India. Record Type: 483

Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarring) or with compensated cirrhosis.

FDA Warns Retailers Selling Illegal Tobacco Products That Look Like Everyday Products

Excel Vision - 01/22/2026. Country: France. Record Type: 483

FDA continues to implement its bold food agenda, with two decisive actions focused on food chemical safety.

FDA announced it is soliciting input on efforts with respect to drug repurposing to help address unmet medical needs across a range of diseases and conditions.

FDA issued an approval for Bizengri (zenocutuzumab-zbco), a drug that treats NRG1 fusion-positive cholangiocarcinoma, an ultra-rare, aggressive cancer that forms in the bile ducts.

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 4/09/2026 Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 4/09/2026 FEI Number 3011761321 Firm Name Wells Pharmacy Inc Record Type 483 State TN Establishment Type Outsourcing Facility

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 2/20/2026 Short Title (70 char) Staska Pharmaceuticals, Inc. Bennett, NE. 483 issued 02/20/2026 FEI Number 3017473850 Firm Name Staska Pharmaceuticals, Inc Record Type 483 State NE Establishment Type Outsourcing

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.

Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 3/13/2026 Short Title (70 char) SCA Pharmaceuticals LLC. Windsor, CT. 483 issued 03/13/2026 FEI Number 3013736415 Firm Name SCA Pharmaceuticals LLC Record Type 483 State CT Establishment Type Outsourcing Facilit

Somerset Therapeutics Private Limited - 02/21/2025. Country: India. Record Type: 483

Shouguang Fukang Pharmaceutical Co., Ltd. - 02/21/2025. Country: China. Record Type: 483

FDA announced major steps in its bold initiative to modernize the agency. The agency launched Elsa 4.0, a significant upgrade to the agency’s internal AI tool available to all FDA staff, from scientific reviewers to investigators.

Bio-Thera Solutions, Ltd. - 01/17/2025. Country: China. Record Type: 483

FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.

Ajinomoto Company Inc. - 02/21/2025. Country: Japan. Record Type: 483

FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.

FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.