FDA Newsfeed

… Service Commissioned Corps officers, or FDA’s civilians who have volunteered … few weeks, hundreds of dedicated FDA experts have also been working … appreciate the work of all FDA staff responding to these disasters, including the approximately 350 FDA staff who have deployed or …

… reads: AGILENT TECHNOLOGIES RECEIVES EXPANDED FDA APPROVAL FOR THE USE OF … .S. Food and Drug Administration (FDA), for use as an aid … United States and Canada). The FDA also announced on September 22 … . First approved by U.S. FDA in October 2015, for determining …

… to be thrown away. The FDA recently approved two colonoscopes that … February 2015, which triggered an FDA warning the next day. Those … . More recently, in January, the FDA issued a safety alert about … leak into the duodenoscope.” The FDA urged hospitals to immediately remove …

… Squibb’S Opdivo (Nivolumab) receives FDA approval for the treatment of … treated with Sorafenib * ‍U.S. FDA approved Opdivo (Nivolumab) injection for …

… .S. Food and Drug Administration (FDA) for the Biologics License Application … gain a full understanding of FDA requirements for U.S. approval … upon the request of the FDA, the committee reviews and evaluates … on its evaluation; however, the FDA makes the final decision on …

… company said on Friday. The FDA’s decision is in keeping … recommendation in August that the FDA reject the drug. Panelists were … “gain a full understanding of FDA requirements for U.S. approval … South America. In April the FDA declined to approve a rheumatoid …

… .S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection …

… .S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection …

… company said on Friday. The FDA’s decision is in keeping … recommendation in August that the FDA reject the drug. Panelists were …

… , the acting director of the FDA’s Office of Device Evaluation … to be thrown away. The FDA recently approved two colonoscopes that … . More recently, in January, the FDA issued a safety alert about … into the duodenoscope." The FDA urged hospitals to immediately remove …

… .S. Food and Drug Administration (FDA) regarding its Supplemental New Drug … disorder. Upon its preliminary review, FDA determined that the sNDA for … ;We are disappointed with the FDA decision on our submission. We will request a meeting with FDA to discuss and determine our …

… .S. Food and Drug Administration (FDA), for use as an aid … United States and Canada). The FDA also announced on September 22 … . First approved by U.S. FDA in October 2015, for determining … pleased that the U.S. FDA approved the expansion of use …

… refusal to file letter from FDA for Vraylar (Cariprazine) supplemental new … refusal to file letter from FDA for Vraylar (Cariprazine) supplemental new … * Allergan-‍upon its preliminary review, FDA determined SNDA for treatment of … of planning a meeting with FDA​ Source text for Eikon: Further …

… company said on Friday. The FDA’s decision is in keeping … recommendation in August that the FDA reject the drug. Panelists were … “gain a full understanding of FDA requirements for U.S. approval … ’s Kevzara. In April the FDA declined to approve a rheumatoid …

… Inc * Agilent Technologies receives expanded FDA approval for the use of …

… ) - Merck & Co Inc * Fda approves Merck’s keytruda® (pembrolizumab … than or equal to 1) * FDA ‍approves co’s keytruda (pembrolizumab …

… .S. Food and Drug Administration (FDA) has approved KEYTRUDA(pembrolizumab), the … indication is approved under the FDA's accelerated approval regulations …

… eight of the deaths the FDA investigated, seven involved worsening PBC … 20 mg per week. The FDA recommends that health care professionals … or severe liver impairment,” the FDA advises. “In all patients treated … Ocaliva side effects to the FDA’s MedWatch adverse event reporting …

… .S. Food and Drug Administration (FDA), after the agency failed to … July 2014, calling for the FDA to ban over-the-counter benzocaine products … Citizen filed its petition, the FDA has neither granted nor denied … seeks a declaration that the FDA has acted unlawfully by withholding …

… ; the analyst continued. Also, the FDA's "narrative about … $120 price target. Related Link: FDA Warning Letter Buckles Intercept Pharma … Stock Potential Be Blindsided By FDA Letter? Latest Ratings for ICPT … Ideas News Health Care Reiteration FDA Top Stories Best of Benzinga …

… front came, surprisingly, from the FDA itself. For their work in …

… 7 1998), the FDA Quality System Regulations (FDA Quality System Regulation, 1996 …

… is little doubt that the FDA's letter adds some … $160. Of particular note, the FDA's letter is unlikely … , the analyst added. Also, the FDA's letter should have … Ideas News Health Care Reiteration FDA Analyst Ratings Best of Benzinga …

… , the acting director of the FDA’s Office of Device Evaluation … that are fully disposable. The FDA recently approved two colonoscopes that … February 2015, which triggered an FDA warning the next day. Those … leak into the duodenoscope.” The FDA urged hospitals to immediately remove …