22 articles tagged with "FDA"
A small biotech firm has ceased operations following a significant delay in securing FDA approval for its clinical trial plan, highlighting the critical nature of regulatory timelines.
GE HealthCare has secured FDA clearance for its Photonova Spectra CT system, a development that may influence diagnostic imaging capabilities and market dynamics.
The FDA's evolving criteria for 'breakthrough' device designation is examined, focusing on AI-powered technologies and their implications for medical infrastructure.
The FDA's recent approval of a new obesity treatment from Lilly coincides with the Trump administration's plans for a significant tariff on certain patented drugs.
The FDA has approved Foundayo, a daily oral medication for obesity management, which will compete with the injectable Wegovy. This approval was expedited by the agency.
A recent review highlights the FDA's inconsistent disclosure of financial conflicts of interest among advisory committee members, emphasizing the need for new guidance.
The FDA's potential shift on injectable peptide compounding could reshape industry practices, previously hindered by safety concerns. The ongoing conflict in Iran is also affecting trial recruitment.
The FDA's approval of Denali Medicine's treatment for Hunter syndrome indicates a pivotal moment in the regulatory landscape for rare disease therapies, amidst heightened scrutiny.
The FDA's recent approval of Denali Therapeutics' drug for Hunter syndrome signifies a pivotal change in regulatory attitudes towards rare disease therapies.
Robert Califf, the former FDA commissioner, raises concerns about the increasing political influence on the FDA during the Trump administration, affecting decision-making processes.
GE HealthCare has received FDA 510(k) clearance for its latest product, which is anticipated to enhance patient outcomes and strengthen its healthcare technology portfolio.
The FDA's increased scrutiny on telehealth marketing for GLP-1 drugs could reshape prescribing practices and impact telehealth companies.
The FDA's recent approval of Leucovorin for a rare disorder, lacking conventional trial data, prompts a reevaluation of drug evaluation protocols and potential impacts on infrastructure.
The FDA has issued a warning to Novo Nordisk regarding product safety, while Lilly is increasing its investment in China to bolster market presence.
Senator Ron Johnson is scrutinizing the FDA's rejection of treatments for rare diseases, following a discussion with Commissioner Marty Makary that raised significant concerns.
The FDA's recent warning to Novo Nordisk highlights ongoing concerns regarding the company's reporting practices for GLP-1 drugs, particularly related to potential side effects.
The FDA has approved leucovorin as the first drug for a specific rare genetic disorder, following discussions about its efficacy in autism treatment.
The co-founders of BioNTech are leaving to establish a new mRNA-focused company, prompting a U.S. senator to investigate the FDA's oversight.
The FDA's approval of Opill as the first OTC oral contraceptive represents a pivotal shift in contraceptive access, impacting healthcare infrastructure and distribution channels.
The FDA's decreasing reliance on advisory committees is raising alarms among stakeholders, with potential ramifications for drug approval processes and public discourse.
Recent FDA decisions could complicate the Trump administration's relationship with drugmaker UniQure.
China has approved a new obesity treatment from Pfizer, heightening competition in a market poised to become even more crowded.