Latest news with #BiologicsLicenseApplications
Yahoo
20-05-2025
- Business
- Yahoo
Moderna Stock Jumps on New FDA COVID-19 Booster Guidelines
Shares of Moderna surged to lead S&P 500 gainers in early afternoon trading Tuesday, hours after the Food and Drug Administration (FDA) issued new guidance for COVID-19 vaccine boosters for healthy Americans under age 65. FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research director Vinay Prasad wrote in The New England Journal of Medicine that the agency's "new Covid-19 philosophy represents a balance of regulatory flexibility and a commitment to gold-standard science. The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk." Dr. Prasad and Dr. Makary added that "for all healthy persons—those with no risk factors for severe Covid-19—between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted." The expected uptick in new trials benefited shares of vaccine producers Tuesday. In addition to Moderna's nearly 8% gains Tuesday, U.S.-listed shares of BioNTech (BNTX) advanced about 4%, and Pfizer (PFE) stock rose 2%. Despite having risen nearly 20% over the past three sessions, shares of Moderna have lost about a third of their value this year. Read the original article on Investopedia Sign in to access your portfolio
Associated Press
20-05-2025
- Business
- Associated Press
The FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: June 11-12, 2025)
DUBLIN--(BUSINESS WIRE)--May 20, 2025-- The 'The FDA (Food and Drug Administration) Drug Approval Process Training Course' training has been added to offering. This programme will be especially beneficial to those responsible for preparing US registration documents (INDs,NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs. There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning. Benefits of attending: Certifications: Key Topics Covered: Day 1 Pharmaceutical Medicine and Documents FDA History and Organisation Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA) Legal Basis Continued Application and Submissions Types Refusal to File Investigational New Drug (IND) Applications Getting Products to the Market Faster FDA Meetings and Documentation CTD Content - Setting the Scene CTD Content - M1 Day 2 CTD Content - M3 and Corresponding M2 CTD Content - M4 and Corresponding M2 CTD Content - M5 and Corresponding M2 Submission Format and Methods US Amendment Procedures High Level Comparison US vs EU Case Study For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 05/20/2025 08:25 AM/DISC: 05/20/2025 08:24 AM
