Impact Stories
Stories illustrating how regulatory science impacts the lives and health of people
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FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations
On July 2, 2025, the Food and Drug Administration granted accelerated approval to sunvozertinib (Zegfrovy, Dizal (Jiangsu) Pharmaceutical Co., Ltd.) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertio -
FDA approves mitomycin intravesical solution for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer
On June 12, 2025, the Food and Drug Administration approved mitomycin intravesical solution (Zusduri, UroGen Pharma) for adult patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). -
Genetic Metabolic Diseases Advisory Committee Roster
Genetic Metabolic Diseases Advisory Committee Roster lists the current members and the current number of vacancies for the committee. -
Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place
Abbott Medical is removing power cords associated with the HeartMate Mobile Power Unit due to a potential risk of the cord not locking into place. -
Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation
Hamilton Medical is recalling certain coaxial breathing sets due to a defect that may cause cracks in the inner tube, risking patient rebreathing exhaled gases. -
Spectrum Laboratory Products, Inc. Issues Voluntary Worldwide Recall of Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient (API) Due to Discoloration of Product
Spectrum Laboratory Products, Inc. is voluntarily recalling three lots of Epinephrine (L-Adrenaline) USP, a bulk active pharmaceutical ingredient (API) used to manufacture or compound prescription products, to the user level. Customer complaints have found the product to be discolored. -
KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged
Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distrib -
FDA Launches Crackdown on Deceptive Drug Advertising
The U.S. Department of Health and Human Services and the Food and Drug Administration today announced sweeping reforms to rein in misleading direct-to-consumer pharmaceutical advertisements. -
FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
On September 9, 2025, the Food and Drug Administration approved gemcitabine intravesical system (Inlexzo, Janssen Biotech, Inc.) for adults with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors -
Field Safety Notices: 1 to 5 September 2025
List of Field Safety Notices from 1 to 5 September 2025.
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Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
The FDA aspires to assist applicants in developing abbreviated new drug applications (ANDAs). To facilitate the development of an ANDA, agency provides the following resources on ANDA forms and submission requirements.