FDA Focus & Policy Changes - FDA commissioner highlights efforts to rebuild public trust through radical transparency, emphasizing that the government is not your doctor and advocating for individual consultations with healthcare providers [4] - The agency is taking an evidence-based approach to vaccine recommendations, particularly regarding boosters for young, healthy individuals, citing concerns about myocarditis risks and questioning the need for repeated doses without sufficient clinical trials [6][7] - FDA aims to ensure vaccines are available to those who want them, emphasizing the decision is between individuals and their doctors, separate from insurance coverage policies [9][10] - FDA is committed to determining the safety and effectiveness of submitted applications, moving away from rubber-stamping vaccines without clinical trials, especially for young, healthy individuals [12][13] Streamlining Drug Approval & Innovation - FDA is addressing the root causes of health issues, including environmental exposures and chemicals in food, and is inventorying over 1,000 chemicals banned in Europe but present in the US food supply [17] - The agency is working to remove all nine petroleum-based food dyes from the US food supply by next year and is seeking innovation in baby formula, addressing the lack of updates to the FDA recipe in 30 years [18] - FDA is questioning why it takes ten years for a drug to come to market and is implementing programs to reduce animal testing, replace it with computational modeling and organ-on-a-chip technology, and expedite decision-making processes [19][20] - The agency is piloting a priority pathway to potentially reduce decision times to weeks instead of a year and is exploring the use of AI in the review process [20] - FDA is making drug rejection letters public in real-time to increase transparency and predictability for drug developers and investors [21][39] National Priorities & Post-Market Surveillance - FDA is prioritizing large unmet public health needs, domestic manufacturing, and drug affordability as national priorities, aiming to lower drug prices for Americans [23][24][25] - The agency is establishing a post-market surveillance program using big data to monitor drugs immediately after approval, aiming to detect potential issues earlier and potentially change the threshold for approval, especially for rare diseases [26][27] - FDA is interested in seeing cures for type one diabetes, more effective cancer therapies, a universal flu shot, and treatments for neurodegenerative diseases [29][30] FDA Restructuring & Efficiency - FDA has not laid off scientific reviewers or inspectors but has implemented early retirements and is actively hiring scientific reviewers [31][32] - The agency is consolidating redundant services and addressing the "empire building culture" within its centers to improve efficiency and accountability [33][34] - FDA is consolidating its ten different adverse event reporting systems into one to create a better user interface and database for post-market surveillance of drugs [35][36]

US regulators approved Moderna’s Covid vaccine for children, a positive sign for the company amid Robert F. Kennedy Jr.’s policy positions that have led to restricted access to the shots for kids https://t.co/nIBtdAkS25 ...

The American Academy of Pediatrics is suing HHS Secretary RFK Jr. . saying, quote, "We believe the children deserve better." The lawsuit alleges changes to COVID vaccine recommendations without a scientific reason. And Kennedy's firing of vaccine advisors, replacing them with multiple vaccine skeptics, are illegal and are outside established scientific practice.Joining us now, the president of the American Academy of Pediatrics, Dr. . Susan Cresley. Uh, doctor, thank you so much for joining us.Um, please ex ...

The House Judiciary Committee subpoenaed a former Pfizer executive, demanding he address allegations of deliberately delaying positive news from the company’s Covid vaccine study until after the 2020 election https://t.co/vUf0tiatFl ...

Pfizer (PFE) FY Conference June 09, 2025 08:00 AM ET Speaker0 Great. Good morning, everyone, and welcome to our forty sixth Annual Global Healthcare Conference. My name is Assad Heather. I'm The U. S. Pharma Analyst here at Goldman Sachs. And we are very privileged to have Albert Bula with us to kick up this conference. Albert's the CEO of Pfizer. Albert, thank you for being with us. Speaker1 Great pleasure. Speaker0 Albert, we have about thirty five minutes, so I wanna start with a big picture question for ...

Moderna (MRNA) 2025 Conference June 05, 2025 10:30 AM ET Speaker0 Everyone, thank you. Good morning, and thank you for joining us on our next discussion here at the Jefferies Healthcare Conference. I have the pleasure of having the President of Moderna, Stephen Hoag, up here with us. Obviously, timely. A lot's going on in the world, both from a regulatory administrative standpoint. We had Marty Makary here yesterday. Obviously, a lot going on with your commercial business, the pipeline, all of that. So I lo ...

Company Overview - Moderna is focused on building a diverse portfolio of products utilizing mRNA technology, targeting areas such as infectious diseases, cancer, rare diseases, and autoimmune diseases [3]. Strategic Priorities - The company has outlined three main priorities for the year: 1. To drive sales through approved products, specifically COVID-19 and RSV vaccines [3]. 2. To launch new products to diversify and grow the top line, with up to 10 launches planned over the next few years and several Biologics License Applications (BLAs) already filed [4]. 3. To resize the company from a cost perspective in response to the transition from pandemic-related sales [4].

If you see a stock that pays 6% in dividends, you might assume it's too risky -- but that's not always the case. In some situations, a yield can grow to such heights because investors have been dumping the stock. This can occur due to concerns around a company's business, including poor financial results. It's not a good idea to assume that a high-yielding dividend always means that a reduction in the payout is inevitable. An assumption like that could result in an investor missing out on some great dividen ...

About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...

Moderna (MRNA) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good day, and thank you for standing by. Welcome to the Moderna first quarter '20 '20 '5 conference call. At this time, all participants are in a listen only mode. After the speakers' presentation, there'll be a question and answer session. To ask a question during the session, you need to press 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press 11 again. Pl ...