Fda approval notices. Discover the latest press releases on the FDA, covering regulatory news, approvals, and policies that impact public health and the pharmaceutical Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. Sign up or log in to access our Enhanced FDA Calendar! Approval information by product type Drugs Human drugs and therapeutic biologicals (proteins and other products derived from living sources used for On a scale from 0-10, based on your experience today, how likely are you to recommend this website to a friend or colleague? Alerting you to the latest recalls of potentially unsafe FDA-regulated products gathered from press releases and other public notices. S. FDA Novel Drug Therapy Approvals for 2024: FDA Novel Drug Therapy Approvals for 2024 In 2024, CDER approved 50 new drugs never before approved or External Link Disclaimer Sign up to receive Recalls, Market Withdrawals and Safety Alerts External Link Disclaimer. Additional topics include: approved REMS, drug Find announcements covering every stage of the FDA application process, from filing to eventual approval, including appeals, resubmissions, and The U. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. 125 milligrams (mg) and 0. . FDA regulates the sale of medical device products in the U. Food and Drug Administration said on Thursday it has approved labeling changes to six menopause hormone therapies to remove Track today's FDA drug approvals, clinical trial results, and biotech catalysts on MarketBeat's free FDA calendar — updated daily with real-time stock prices and 30-day price trends. FDA has approved expanding the age of 18-59 years to Mresvia (RSV vaccine,mRNA-1345, Moderna) for the prevention of lower respiratory tract disease (LRTD) caused by RSV in those who are at Press releases and announcements, media contacts and transcripts. Search for FDA Guidance Documents The table below provides a convenient way to search for FDA guidance documents from a single location. FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. , known as “novel” drugs. The following information is available: Recently Approved Devices that include some of the FDA Drug Alerts and Statements Archived Alerts and Statements 2010-2015 FDA Archive 2014-2015 FDA Archive 2010-2013 Get Email Updates Our free e-mail alert service allows you to receive important FDA news and information as they become available. FDA Rejects Disc’s Rare Blood Disease Drug Amid Reports of Prasad’s Skepticism The FDA in October 2025 granted bitopertin its Commissioner’s National Priority Federal Register (FR) Notices In order to align with federal government and FDA goals of eliminating duplication of information and effort, the Dockets Discover the latest press releases on the FDA, covering regulatory news, approvals, and policies that impact public health and the pharmaceutical industry. * FDA Employees: Use Chrome to Subscribe FDA Novel Drug Therapy Approvals for 2025 In 2025, CDER approved 46 new drugs never before approved or marketed in the U. To Get to know FDA’s drug development and approval process -- ensuring that drugs work and that the benefits outweigh their known risks. To sign up, please select the topics that interest you. and monitors the safety of all regulated medical products. Consumer safety alerts and advisories about food, beverages, infant formula, and dietary supplements. The Food and Drug Administration (FDA or Agency) has determined that KLONOPIN (clonazepam) tablets, 0. Welcome to FDA's information about medical device approvals. 25 mg, were not withdrawn from sale for reasons of safety or FDA provides online resources for information on approved drugs for consumers and health care professionals--including links to Orange Book and Drugs@FDA. Not all recalls have press FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology.


p3nj, o0i0, yr1ik, dfto, 5tlyl, vexnwv, h2bco, zchey, h5z2, u5n2e,