FDA Drug Regulation & Scheduling
Material regulatory developments from U.S. Food and Drug Administration and U.S. Drug Enforcement Administration are tracked daily by Cresthaven Analytics. Over the last 90 days, 20 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
A selection of recent published briefs; this is not a complete archive.
FDA advises consumers against Miracle Power of King Kong Honey over undisclosed active pharmaceutical ingredient
The FDA issued a consumer safety advisory on September 25, 2026 warning against purchasing or using Miracle Power of King Kong Honey, a sexual enhancement product sold online and potentially in retail stores. The advisor…
Read the full FDA Drug Regulation & Scheduling brief →FDA advises consumers against Candy Power For Man sexual enhancement product containing undisclosed ingredient
The FDA issued a consumer safety advisory on September 25, 2026 warning against purchasing or using Candy Power For Man, a sexual enhancement product sold on websites including eBay and potentially in retail stores. The …
Read the full FDA Drug Regulation & Scheduling brief →FDA advises consumers against purchasing Vital Honey over undisclosed drug ingredient
On September 25, 2026, the FDA advised consumers not to purchase or use Vital Honey, a sexual enhancement product sold on multiple websites and potentially in retail stores. The product contains an undisclosed drug ingre…
Read the full FDA Drug Regulation & Scheduling brief →FDA approves zilurgisertib as third treatment for fibrodysplasia ossificans progressiva in patients aged 12 and older
FDA approved Atebrioz (zilurgisertib) tablets on September 25, 2026 for adults and pediatric patients aged 12 and older with fibrodysplasia ossificans progressiva. The approval targets reduction in total new heterotopic …
Read the full FDA Drug Regulation & Scheduling brief →FDA approves obinutuzumab for relapse prevention in idiopathic nephrotic syndrome patients aged 2 and older
FDA approved Gazyva (obinutuzumab) injection on September 25, 2026 for frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome in patients 2 years and older who are in remission. This mar…
Read the full FDA Drug Regulation & Scheduling brief →FDA permanently debars Naveed Aslam from drug product application services following federal felony conviction
FDA issued a final debarment order on September 25, 2026, permanently barring Naveed Aslam from providing services in any capacity to any holder of an approved or pending drug product application. The order follows a fed…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues 10-year import debarment against Jeffrey Thies for counterfeit drug trafficking convictions
FDA issued a final debarment order on September 25, 2026, barring Jeffrey Thies from importing or offering for import any drug into the United States for 10 years. The order follows two federal felony convictions for tra…
Read the full FDA Drug Regulation & Scheduling brief →FDA opens public comment on BsUFA reauthorization proposals covering fiscal years 2028 through 2032
FDA published proposed recommendations on September 25, 2026 for reauthorization of the Biosimilar User Fee Act (BsUFA), which governs agency collection of fees that support biosimilar application review. The current leg…
Read the full FDA Drug Regulation & Scheduling brief →FDA convenes advisory committee to review atropine sulfate 0.01% ophthalmic solution NDA for myopia progression
FDA has scheduled a public advisory committee meeting to review NDA 219694, an application for atropine sulfate ophthalmic solution 0.01%. The Dermatologic and Ophthalmic Drugs Advisory Committee will conduct the review.…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues CGMP warning letter to American Towelette Company citing data integrity failures and inadequate quality oversight
FDA's Center for Drug Evaluation and Research issued a warning letter on July 30, 2026 to Lico Industries, LLC, doing business as American Towelette Company, following a facility inspection in February 2026. The letter c…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues CGMP warning letter to FairyGene Inc covering unapproved drugs and facility violations
FDA's Center for Drug Evaluation and Research issued a warning letter to FairyGene, Inc. on July 31, 2026, following a January 2026 inspection of its Bristol, Pennsylvania facility. The letter cites CGMP violations, five…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues warning letter and import alert to Indian contract drug manufacturer for records access refusal
FDA's Center for Drug Evaluation and Research issued a warning letter on February 13, 2025, to Zenzi Pharmaceutical Industries Pvt. Ltd. in Maharashtra, India, for refusing to provide records under the foreign records ac…
Read the full FDA Drug Regulation & Scheduling brief →FDA closes warning letter against Zenzi Pharmaceutical but maintains Import Alert 66-79 over inspection refusal
FDA's Center for Drug Evaluation and Research issued a closeout letter on September 18, 2026 to Zenzi Pharmaceutical Industries Private Limited, a Maharashtra-based drug manufacturer. The firm remains on Import Alert 66-…
Read the full FDA Drug Regulation & Scheduling brief →FDA approves belzutifan plus lenvatinib combination for advanced clear cell renal cell carcinoma in adults
The FDA approved belzutifan combined with lenvatinib on September 24, 2026, for adults with advanced renal cell carcinoma with a clear cell component. This expands the labeled indications for both agents. The approval es…
Read the full FDA Drug Regulation & Scheduling brief →FDA Class I recall removes all Automated Impella Controllers globally over purge flag failures linked to 37 injuries and three deaths
The FDA has classified Abiomed's removal of all Automated Impella Controllers as a Class I recall — its most serious designation — following purge flag component failures within the purge pressure sensor assembly. As of …
Read the full FDA Drug Regulation & Scheduling brief →FDA classifies Becton Dickinson convenience kit correction as Class I recall over sterility-compromised sodium chloride ampules
The FDA on September 24, 2026 elevated its August 18 Early Alert for Becton Dickinson convenience kits and procedure trays to a Class I recall classification. The affected kits contain sodium chloride ampules manufacture…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues warning letter to Empower Pharmacy over compounding violations and patient safety deficiencies
FDA's Center for Drug Evaluation and Research issued Warning Letter 738238 to Empower Clinic Services, LLC dba Empower Pharmacy on September 18, 2026, citing serious manufacturing deficiencies identified during a Novembe…
Read the full FDA Drug Regulation & Scheduling brief →HHS opens public docket to determine regulatory framework for deceased donor islet cell therapies for Type 1 diabetes
HHS published a Request for Information on September 24, 2026, seeking data and comments on how to regulate deceased donor islet cells and islet cell products for Type 1 diabetes treatment. The docket specifically explor…
Read the full FDA Drug Regulation & Scheduling brief →FDA approves Onswik, the first once-weekly basal insulin for adults with type 2 diabetes
The FDA approved Onswik (insulin efsitora alfa-gobe) injection on September 24, 2026, as a long-acting insulin analog for glycemic control in adults with type 2 diabetes. This is the first once-weekly basal insulin to re…
Read the full FDA Drug Regulation & Scheduling brief →FDA grants full approval to lirafugratinib for FGFR-altered cholangiocarcinoma in previously treated adults
The FDA approved lirafugratinib (Lyrfigtu, Elevar Therapeutics) on September 23, 2026, as a kinase inhibitor for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a …
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