United States
US FDA Commissioner nominee Martin Makary told Senators that he plans to review the data on the abortion pill mifepristone, raising some lawmakers concerns that older safety requirements the FDA has deemed unnecessary, like in-person dispensing, may be reinstated.
Martin Makary said he would re-evaluate the topics that deserve a Vaccines and Related Biological Products Advisory Committee review, but did not commit to rescheduling the cancelled meeting on influenza vaccine strain selection.
Congress continues to offer broad support for encouraging alternatives to opioid pain medicine, including proposals to speed coverage of new agents like Vertex’ Journavx.
Acting Commissioner Sara Brenner rejected the company’s request for a hearing, saying the lack of an adequate and well-controlled trial showing tasimelteon's effectiveness in treating sleep-onset insomnia is “fatal to the application.”
During his Senate confirmation hearing, Bhattacharya also said he does not believe the MMR vaccine causes autism and emphasized transparency with NIH-funded researcher ties to the pharmaceutical industry.
US FDA Commissioner nominee Martin Makary’s 6 March Senate confirmation hearing should offer insight on his alignment with HHS Secretary Robert F. Kennedy Jr.'s views and willingness to insulate the FDA from an unusual level of micromanagement by the department and White House.
Two recent disclosures from Xbrane Biopharma and Formycon demonstrate the evolving US Food and Drug Administration thinking about the need for Phase III trials to support biosimilar filings.
A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.
The Voluntary Early Retirement Authority (VERA) plan would make many FDA employees with 20 or more years of service eligible for retirement, potentially increasing senior staff departures as the agency develops more layoff plans.
FDA Commissioner nominee Martin Makary can comply with US ethics laws while weighing in on the contentious GLP-1 compounding debate, despite recently exiting a company that connects patients with compounded semaglutide and an ophthalmology compounding business.
Lilly is broadening the range of single-use vial dosage forms of its obesity drug and lowering prices of existing doses for self-paying customers, but maintains it can handle increased demand as compounding ends.
The explosion in pharmacy compounding as a source of GLP-1 weight loss medications has put the FDA in a tough spot to defend its drug shortage policies, but it is not the first time that compounding has posed a potentially significant threat to agency authorities.
March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.
The FY 2024 fourth quarter had the highest number of formal meetings cancelled because written responses were sufficient since the beginning of FY 2018.
Sponsors should consider the DTC ad's audio as the major statement about a prescription drug’s side effects and then choose strategically how to display the accompanying text. TV ads are now employing banners and larger text to satisfy the rule’s “dual modality” requirement.
Reporter and editors from the Pink Sheet and Medtech Insight discuss the impact of the FDA’s decision to call back many of the employees it laid off, the decision to cancel an upcoming FDA advisory committee meeting on flu vaccines, and Eli Lilly’s plans to increase domestic manufacturing.
The US FDA is expected to refine warnings recently added to CAR-T cell therapies about the risk of secondary malignancies after reassuring new data, which is a positive sign for the future of the therapies in autoimmune disorders.
HHS Secretary Robert F. Kennedy Jr. is nostalgic for the 1960s. Will that include pushing the agency back to the pre-user-fee-era model of defining success based on blocking unsafe drugs, rather than accelerating access to effective ones?
The Risk Evaluation and Mitigation Strategy hindered access and burdened the health care system even though it was never fully implemented or enforced. The FDA still recommends prescribers monitor patients’ absolute neutrophil count to prevent severe neutropenia.
Eli Lilly's move is said to be part of broader industry campaign to invest in America and avoid President Trump's tariffs, but the company also said tax reform is necessary to make the investments.