Drugs
FDA has approved Gilead Sciences' antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC), significantly expanding the drug's role in one of the most aggressive forms of breast cancer. The approval
Drugs
CeleCor Therapeutics says it has submitted an NDA for Disaggpro (zalunfiban), an investigational treatment for ST-segment elevation myocardial infarction (STEMI), the most severe form of heart attack. The filing marks the completion of a rolling NDA after FDA granted a Fast Track designation in January. The company says the
Drugs
The FDA FY 2025 Report on the State of Pharmaceutical Quality shows that in FY 2025, there were 1,248 drug quality assurance inspections, up from 972 such inspections in FY 2024. Of the 1,248 drug quality inspections, 432 (44%) were in the U.S., and 540 (56%) were
Drugs
A newly published commentary in the journal Stem Cell Research & Therapy says FDA’s efforts to reduce reliance on animal testing is driving a fundamental shift toward human-based technologies for evaluating drug safety. The article reviews the agency's first-year progress under its roadmap to reduce
Drugs
The Association for Accessible Medicines (AAM) says an FDA draft guidance on establishing impurity specifications for antibiotics is very general and lacks specific recommendations for setting thresholds for impurities in the products covered by the guidance. In its comment letter, AAM contrasts the FDA draft with one from the European
Drugs
In responding to an FDA Request for Information (RFI) on an AI-enabled optimization of early-phase clinical trials pilot program, the Association of Clinical Research Organizations (ACRO) makes these points: * contract research organizations are a keystone in building the architecture for real-time, continuous clinical trials; * the RFI is
FDA Policy/General
In the first of three planned online posts on FDA’s FY 2027 Appropriations Report, approved by the House Appropriations Committee to explain its agency funding bill, eight Hyman, Phelps & McNamara lawyers say the report “reflects a Congress eager to shape FDA’s regulatory priorities — from promoting artificial intelligence
Drugs
The Federal Trade Commission (FTC) has filed an amicus brief supporting plaintiffs in an antitrust lawsuit accusing Johnson & Johnson of unlawfully maintaining a monopoly over its blockbuster autoimmune drug Stelara through anticompetitive conduct. The case was brought by CareFirst of Maryland, which alleges that J&J preserved its
Drugs
A new CDER Office of New Drugs (OND) webinar discusses the development and use of OND Custom Medical Queries (OCMQs) to identify potential safety signals during review of clinical trial adverse event data in new molecular entity NDAs/BLAs and related supplements. During the webinar, Biomedical Informatics and Regulatory Review
Drugs
A new analysis published in JAMA Psychiatry is raising fresh questions about how FDA evaluates drug efficacy when clinical trial results are mixed, using the decades-long regulatory journey of the antidepressant Exxua (gepirone) extended release as a case study. In a Special Communication published 6/24, researchers examined the
Drugs
FDA has published the CDER 2025 Drug Trials Snapshot Summary Report with summarized baseline demographic information from pivotal trials that supported the approval of 46 novel drugs in 2025. The report says that 20 (43%) of the approved novel drugs were first-in-class, while 23 (50%) were indicated to
Drugs
FDA has issued Achieve Life Sciences a Complete Response Letter (CRL) on its NDA for cytisinicline as a treatment for nicotine dependence. “The CRL relates to outstanding manufacturing-related observations from a current Good Manufacturing Practice (cGMP) inspection of a third-party manufacturing facility and to final product labeling that
Drugs
FDA has released the form FDA-483 issued following a 3/30-4/8 inspection at Pharmaneek, an Indianapolis, IN, producer of non-sterile drug products. The form FDA-483 says the specific inspection observations were: * production of hazardous drugs without providing adequate containment, segregation, and/or cleaning of work
Drugs
Real-world evidence (RWE) generated from real-world data (RWD) remains underutilized in drug approvals. That’s the report from several drug company officials, including one former FDAer, writing in Therapeutic Innovation & Regulatory Science. The authors note that beyond the fundamental need for relevant and reliable RWD, three interdependent
Drugs
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Drugs
A 10/20-11/3/2025 FDA inspection at the Jubilant HollisterStier General Partnership drug manufacturing facility in Kirkland, Quebec, Canada, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 5/28 Warning Letter says the specific violations were: * failure to establish and
Drugs
A 11/12-11/21/2025 FDA inspection at the Huons Co. drug manufacturing facility in Jecheon, Chungcheongbuk, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/15 Warning Letter says the four specific violations were: * failure to ensure that laboratory records
FDA Policy/General
A Skadden Insights post says the departure of former FDA commissioner Marty Makary and several of his senior executives has led to regulatory uncertainty in regulated companies. “Many of the initiatives that defined the Makary era were never enshrined in formal rules or guidance, but rather were announced by press
Drugs
FDA says it purchased three unapproved new drugs from the Amazon Web site and directed the company to address the violations promptly and ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence. A 6/17 Warning Letter says two of the products were indicated
Drugs
FDA has released a draft guidance outlining how sponsors can use quantitative systems pharmacology (QSP) models to determine starting doses for first-in-human (FIH) clinical trials, particularly for higher-risk therapies where traditional animal-based approaches may be less predictive. The document focuses on using QSP models to estimate
Drugs
FDA has issued a revised draft guidance that updates how sponsors can demonstrate "substantial evidence" of effectiveness for new drugs and biologics, reflecting advances in clinical trial design, real-world evidence, and precision medicine. The document is part of an HHS and FDA initiative (see story) to help
Drugs
FDA has released a revised draft guidance aimed at helping sponsors design and conduct clinical trials using master protocols, a trial framework increasingly used to evaluate multiple therapies, diseases, or patient populations within a single overarching study. The draft guidance, Master Protocols for Drug and Biological Product Development, replaces a