FDA Newsfeed

… contraindications to estrogen therapy. The FDA approved fosfomycin injection (Contepo; … amid rising antimicrobial resistance. The FDA approved Nuzolvence (zoliflodacin; Innoviva … decision makes Addyi the first FDA-approved, nonhormonal pharmacologic therapy …

… complaint argued that the FDA failed to consider evidence … standing to sue because FDA regulation of medication abortion … Bloomberg reported that the FDA had quietly postponed its … are unconstitutional or that the FDA acted illegally, courts could …

… the Food and Drug Administration (FDA) in September, despite earlier promises … to ‘destigmatize abortion’ […] Critics Blast FDA For Approving ‘Politically Driven’ Abortion …

… . “Through these engagements, the FDA brought regulatory and advisory services … read. Alongside reform, the FDA intensified inspection and enforcement activities … following intervention. Beyond enforcement, the FDA expanded community outreach by supporting …

… highlights the most notable FDA decisions expected in early 2026 … Disease In 2025, the FDA approved a subcutaneous autoinjector ( … Parkinson-s-Disease.html 8. FDA Approves LEQEMBI® IQLIK™ ( … 10. Denali Therapeutics announces FDA review extension of BLA for …

The FDA has approved tradipitant (Nereus), an …

… Food and Drug Administration (FDA) carried out an inspection … its management operations. The FDA routinely inspects facilities across the … products are compliant with FDA-regulated laws and regulations … to its website, the FDA is a government agency that …

… regarding its operational management. The FDA routinely inspects facilities across the … their products are compliant with FDA-regulated laws and regulations implemented … . According to its website, the FDA is a government agency that …

… in 2026. Abbott (ABT) Wins FDA Approval for Volt PFA System … stop irregular heart rhythms. The FDA approval was based on results …

… Stocks to Buy in 2026. FDA Fast-Tracks Two Merck (MRK … initiative, the documents show. The FDA expects Merck & Co., Inc … program is designed to accelerate FDA decisions for drugs with major …

… Food and Drug Administration’s (FDA) approval of Novo’s weight … in November 2023, when the FDA approved Eli Lilly and Company … approved. Most expect that the FDA will approve orforglipron, but not … treatment to new patients. What FDA Approval of the Wegovy Pill …

… S. Food & Drug Administration (FDA) announced a recall on dozens … multiple states. According to the FDA, it was determined that the … reported to date; however, the FDA stated that when handled or … distributed is outlined in the FDA announcement, as well as a …

The U.S. FDA has approved its first pharma … Gastrointestinal Small molecule U.S. FDA

… -clinical trials leading to two FDA-approved clinical trials by UC …

… . Outlook said on Wednesday the FDA concluded that additional data provided … efficacy to support approval. The FDA has not indicated what type … to address some of the FDA’s previous concerns, the drug …

… .S. Food and Drug Administration (FDA) has officially cleared Deseyne contact … industry.” Catalfamo continued, “U.S. FDA approval is a major milestone … who guided us throughout the FDA clearance process to launch a …

… -controlled study demonstrated efficacy, the FDA again recommended that confirmatory evidence … physicians with a safe, consistent, FDA-approved alternative to compounded Avastin … License Application (BLA) resubmission. The FDA stated that the additional data …

… last week. The recall involved FDA-regulation products from Gold Star … , pet foods, and cosmetics. The FDA discovered numerous instances of unhygienic … where products are stored. The FDA believes they represent a significant …

… (NCT03924895) and the November 2025 FDA approval of enfortumab vedotin-ejfv … contextualized the significance of this FDA approval in addressing a longstanding …

… Food and Drug Administration (FDA) carried out an inspection … its operational management. The FDA routinely inspects facilities across the … products are compliant with FDA-regulated laws and regulations … to its website, the FDA is a government agency that …

… Food and Drug Administration (FDA) has issued a Complete … Outlook Therapeutics announced the FDA’s acceptance of a new … protocol assessment with the FDA. Investigators did note the … with a safe, consistent, FDA-approved alternative to compounded Avastin …

… Food and Drug Administration (FDA) has issued a Complete … Outlook Therapeutics announced the FDA’s acceptance of a new … protocol assessment with the FDA. Investigators did note the … with a safe, consistent, FDA-approved alternative to compounded Avastin …

… withdrew its application ‍following an FDA request for additional information. The … . Outlook said on Wednesday the FDA concluded that additional ‍data provided …

The FDA approved 2 denosumuab biosimilars, Boncresa … reaction.1 This year, the FDA approved multiple biosimilars referencing denosumab … (denosumab-desu; Accord BioPharma). “The FDA approval of our denosumab biosimilars …

… Chief of Staff of the FDA | Official Website DA, Elizabeth … its management operations. The FDA routinely inspects facilities across the … their products are compliant with FDA-regulated laws and regulations … to its website, the FDA is a government agency that …