#FDA

editorial-staff 2 days ago

FDA's Rejection of AI Device Deregulation Proposal Signals Ongoing Safety Concerns

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.

editorial-staff 3 days ago

FDA Proposes Enhanced Oversight of Direct-to-Consumer Advertising as EU Strengthens AMR Commitment

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.

editorial-staff Updated 4 days ago

Judge refuses to block sending abortion pill by mail for now, but says FDA must finish review

A federal judge Tuesday refused to block filling prescriptions for the abortion pill mifepristone by mail across the U.S. — at least for now.

editorial-staff 4 days ago

FDA Proposes Policies to Encourage Domestic Drug Production

Strategic angle: The FDA aims to boost domestic drug manufacturing through new policies outlined in the president's budget.

editorial-staff Updated 5 days ago

How a four-month FDA delay forced a small biotech company to close its doors

A small biotech company faced a critical setback due to a delayed agreement with the FDA, leading to its closure.

editorial-staff 6 days ago

Briefing: GE HealthCare (GEHC) Receives FDA Clearance for Photonova Spectra CT System

Strategic angle: GE HealthCare has announced the FDA clearance for its innovative Photonova Spectra CT system.

editorial-staff 9 days ago

Briefing: FDA’s Evolving View of What Makes a ‘Breakthrough’ Device

Strategic angle: An analysis of AI-powered devices that received the FDA's 'breakthrough' label.

editorial-staff 9 days ago

Briefing: Trump Administration Plans 100% Tariff on Patented Medicines

Strategic angle: The FDA approves a new obesity pill from Lilly amidst tariff discussions.

Politics

Briefing: The FDA approves a new obesity pill, giving patients another option

Strategic angle: The daily pill called Foundayo got a fast track through the Food and Drug Administration.

editorial-staff 10 days ago

editorial-staff 10 days ago

Briefing: Government watchdog urges FDA to finalize guidance for advisory committee conflicts of interest

Strategic angle: A new review reveals the FDA's shortcomings in disclosing financial conflicts of interest among advisory committee members.

editorial-staff 10 days ago

Briefing: FDA Moves Toward Allowing Injectable Peptide Compounding

Strategic angle: The FDA is reconsidering its stance on compounding pharmacies, potentially allowing the production of injectable peptides previously banned due to safety concerns.

editorial-staff Updated 16 days ago

FDA Approves Denali Therapeutics Drug for Hunter Syndrome

A significant decision by the FDA following previous rejections of rare disease treatments.

editorial-staff 23 days ago

Briefing: Political influence ‘a serious problem’ for FDA under Trump, former commissioner says

Strategic angle: Robert Califf highlights the shift towards political decision-making in the FDA during the Trump administration.

editorial-staff 28 days ago

Briefing: GE HealthCare (GEHC) Receives FDA 510 (k) Clearance for View

Strategic angle: GE HealthCare has secured FDA clearance for its new product, enhancing its market position.

Briefing: FDA Targets Telehealth Marketing of GLP-1 Drugs

Strategic angle: The FDA is scrutinizing telehealth marketing practices for GLP-1 drugs, raising questions about prescribing trends.

editorial-staff Updated about 1 month ago

FDA Approves Leucovorin as First Drug for Rare Genetic Disorder

This approval follows previous claims of its potential use in treating autism symptoms.

editorial-staff Updated about 1 month ago

Novo Nordisk is warned by the FDA for failing to report side effects

It's the third time in recent weeks that the FDA has admonished Novo Nordisk for different practices.

Briefing: GOP Senator Investigates FDA Over Rare Disease Drug Rejections

Strategic angle: Sen. Ron Johnson raises concerns about the FDA's handling of treatments for rare diseases after discussions with Commissioner Marty Makary.

Briefing: U.S. Senator Probes FDA Amid BioNTech Founders' Departure

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.

Briefing: Over-the-Counter Oral Contraceptive Pills Approved

Strategic angle: FDA approves Opill, marking a significant change in access to oral contraceptives in the U.S.

Briefing: Lack of FDA Advisory Committees Raises Concerns

Strategic angle: Growing worries about the FDA's diminishing use of advisory committees for public discourse.

Strategic view: FDA's Controversial Actions Against UniQure Raise Political Concerns

Strategic implications in focus: Recent FDA decisions could complicate the Trump administration's relationship with drugmaker UniQure.

Strategic view: FDA-UniQure Tussle and Pfizer's Obesity Drug Approval in China

Strategic implications in focus: China has approved a new obesity treatment from Pfizer, heightening competition in a market poised to become even more crowded.