24 articles tagged with "FDA"
Replimune's cancer drug candidate has been rejected by the FDA for the second time, raising questions and discussions within the medical community.
The FDA has rejected a proposal aimed at easing regulations on specific AI devices, emphasizing the agency's commitment to safety and efficacy in health technology.
Recent developments in the pharmaceutical sector include the FDA's proposal for greater control over direct-to-consumer ads and the EU's commitment to combat antimicrobial resistance.
A federal judge Tuesday refused to block filling prescriptions for the abortion pill mifepristone by mail across the U.S. — at least for now.
Strategic angle: The FDA aims to boost domestic drug manufacturing through new policies outlined in the president's budget.
A small biotech company faced a critical setback due to a delayed agreement with the FDA, leading to its closure.
Strategic angle: GE HealthCare has announced the FDA clearance for its innovative Photonova Spectra CT system.
Strategic angle: An analysis of AI-powered devices that received the FDA's 'breakthrough' label.
Strategic angle: The FDA approves a new obesity pill from Lilly amidst tariff discussions.
Strategic angle: The daily pill called Foundayo got a fast track through the Food and Drug Administration.
Strategic angle: A new review reveals the FDA's shortcomings in disclosing financial conflicts of interest among advisory committee members.
Strategic angle: The FDA is reconsidering its stance on compounding pharmacies, potentially allowing the production of injectable peptides previously banned due to safety concerns.
A significant decision by the FDA following previous rejections of rare disease treatments.
Strategic angle: Robert Califf highlights the shift towards political decision-making in the FDA during the Trump administration.
Strategic angle: GE HealthCare has secured FDA clearance for its new product, enhancing its market position.
Strategic angle: The FDA is scrutinizing telehealth marketing practices for GLP-1 drugs, raising questions about prescribing trends.
This approval follows previous claims of its potential use in treating autism symptoms.
It's the third time in recent weeks that the FDA has admonished Novo Nordisk for different practices.
Strategic angle: Sen. Ron Johnson raises concerns about the FDA's handling of treatments for rare diseases after discussions with Commissioner Marty Makary.
Strategic angle: The co-founders of BioNTech, known for their Covid-19 vaccine, are set to leave the company to launch a new mRNA-focused venture.
Strategic angle: FDA approves Opill, marking a significant change in access to oral contraceptives in the U.S.
Strategic angle: Growing worries about the FDA's diminishing use of advisory committees for public discourse.
Strategic implications in focus: Recent FDA decisions could complicate the Trump administration's relationship with drugmaker UniQure.
Strategic implications in focus: China has approved a new obesity treatment from Pfizer, heightening competition in a market poised to become even more crowded.