FDA Newsfeed

… US Food and Drug Administration (FDA)-approved therapy for recurrent … is proceeding as planned following FDA approval, with rapid and … , PAPZIMEOS remains the only FDA-approved therapy for adults with … In August 2025, the FDA granted full approval of PAPZIMEOS …

… Food and Drug Administration (FDA) has granted Orphan Drug … in advanced disease. "FDA Orphan Drug Designation for our … upon regulatory approval. The FDA's Orphan Drug … #47;novita-pharmaceuticals-announces-fda-orphan-drug-designation-granted-to …

… agricultural practices for produce. “FDA has not fully implemented … . According to GAO, FDA officials said the agency … and assess overall effectiveness. “FDA has reported some performance information … GAO wrote. “However, FDA has not established a performance …

… Food and Drug Administration (FDA), an agency within the … with the requirements. The FDA has delayed Food Traceability … requirements,” GAO reported. “Without FDA doing so, businesses, farmers, … prevent foodborne illnesses. “FDA missed opportunities to assess …

… Food and Drug Administration (FDA) regarding the registrational development … significant unmet need. The FDA also provided separate, supportive … is consistent with prior FDA precedents for single-arm … to continue to secure FDA agreement on the regulatory …

… Food and Drug Administration (FDA) Medical Officer and Global … David Healy, petitioned the FDA to mandate prominent warnings for … drug discontinuation.[5] The FDA failed to act. This … an independent investigation into FDA approval and labeling decisions. …

… Food and Drug Administration (FDA) has granted Premarket Approval … -home neuromodulation treatment with FDA labeling applicable to treatment … of BrainsWay. “This FDA approval represents an exciting … company to obtain three FDA-cleared indications backed by …

… Food and Drug Administration (FDA) has announced increased flexibility for … January 2026, described by FDA commissioner Marty Makary as “ … after approval. Finally, the FDA has dropped the requirement for … Prasad, director of the FDA’s Center for Biologics …

… patients. Currently there are no FDA-approved therapeutics for this difficult … epetraborole as potentially the first FDA-approved therapy for patients with … : SCIENCE BIOTECHNOLOGY RESEARCH PHARMACEUTICAL HEALTH FDA INFECTIOUS DISEASES CLINICAL TRIALS SOURCE …

… .S. Food and Drug Administration (FDA) has cleared its Investigational New … antitrypsin (AAT) expression and function. “FDA clearance of our IND represents … levels. There are currently no FDA-approved therapies that address the …

… orthosurgical products with the US FDA, establishing India as a global … aimed to address the US FDA standards in accordance with … manufacturing in India. The US FDA-registered product line is expansive … the companies to win US FDA approval on 153 orthosurgical …

… a precautionary measure. “The FDA is conducting an ongoing … with the manufacturer, the FDA is verifying the specific … requirements,” it said. The FDA reiterated its commitment to … and consumer protection. “The FDA remains steadfast in fulfilling its …

… South Korean company has received FDA clearance for a Phase 1 …

… biopharmaceuticals has received U.S. FDA clearance to proceed with a … in radiopharmaceutical development. Following the FDA’s clearance, the company is … to critical raw materials. “The FDA’s IND clearance marks a …

… next-generation cancer treatments. The FDA approved the investigational new drug … a Korean company has secured FDA’s clinical trial approval in … therapeutic candidate, the company added. “FDA’s IND (investigational new drug …

… clinical differential. The FDA’s Breakthrough Device Program … medical need. “Receiving FDA Breakthrough Device Designation represents … “This designation reflects the FDA’s recognition of the … Designation does not constitute FDA clearance, approval, or …

… will help guide the FDA’s evaluation of development … regulatory flexibilities allowed under FDA’s regulations that accommodate … Therapeutic Products in the FDA’s Center for Biologics … Related Information ### Boilerplate The FDA, an agency within the …

… posted on the FDA’s website. The FDA’s final report … 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 …

… segmental glomerulosclerosis (FSGS). The FDA’s decision is expected on … Verdict After Delay The FDA was initially scheduled to … is currently under extended FDA review, with a decision … patients’ comfort levels. The FDA was again unimpressed, handing out …

… posted on the FDA’s website. The FDA’s final report … 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 …

… Food and Drug Administration (FDA) conducted an inspection of … 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 …

… ) has won its first keystone FDA clearance Monday, with the United … are hopeful will also see FDA clearance in coming months. For …

… among pregnant women," the FDA said at the time. URGENT … serious risk category. (FDA) Then on Tuesday, the FDA said the recall … POSSIBLE E. COLI CONTAMINATION The FDA said the recall has been …

… the Food and Drug Administration (FDA) carried out an inspection at … of its 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 …