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… .S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® Cohesive … highly cohesive, form-stable gel. The FDA approval of NATRELLE INSPIRA® Cohesive … responsive gel was approved by FDA in February 2015, and the … gel were approved by the FDA in June 2015. "I …

… US Food and Drug Administration (FDA) has granted three simultaneous approvals … patients to gain three simultaneous FDA approvals of ILARIS," said … rare disease community." The FDA approvals are based on results … of the positive data, the FDA granted Ilaris Breakthrough Therapy status …

… US Food and Drug Administration (FDA) may reportedly still engage in … regulations), and Seife suspects the FDA is still clinging to close-hold … lawsuit alleges that the "FDA is unlawfully withholding information… heavily redacted form — regards the FDA's embargo practices. …

… Maharashtra Food and Drug Administration (FDA) has said that its tests … ” in India. Consequently, the state FDA — after testing the products through … . We have challenged this last FDA report and the methodology used … L’Oréal India products, Maharashtra FDA commissioner Harshdeep Kamble told The …

… an experimental drug that the FDA was trying to decide whether … previously been rejected by the FDA, and two others were turned … basis. A letter written by FDA Commissioner Robert Califf laid out … , "but I think the FDA demonstrated the flexibility they are …

… on the ways that the FDA controls who sees information when … impact on American society. The FDA, however, is often releasing announcements … the Clinton-era policy forbidding the FDA to provide advance materials or … citizens to demand better: The FDA should use embargoes responsibly or …

… , M.D., director of the FDA's Center for Drug … criteria specified by law. The FDA's approval of Amjevita …

… one biosimilar cleared by the FDA approval pathway is actually on …

… the market if it gains FDA approval. Sean E. Harper, executive … development at Amgen, called the FDA move "an exciting accomplishment … . In a prepared statement, the FDA said Amgen's Amjevita … Janet Woodcock, director of the FDA's Center for Drug …

… .S. Food and Drug Administration (“FDA”) will require additional time to … an information request from the FDA, additional clinical data analyses have … granted priority review by the FDA with a Prescription Drug User … efficacy, the risk that the FDA and other regulatory authorities may …

… Cancer -- AdjuvantPuma Biotechnology Announces FDA Acceptance of NDA for PB272 … .S. Food and Drug Administration (FDA) has accepted for review the … trastuzumab (Herceptin®)-based therapy. “The FDA acceptance of our NDA is … forward to working with the FDA during their review of this …

… .S. Food and Drug Administration (FDA) has approved Invokamet XR - … States, was initially approved by FDA in August 2014 as an … medications separately. In May 2016, FDA expanded the Invokamet indication to … Articles: Invokamet (canagliflozin and metformin) FDA Approval History View comments

FDA Approves Bayer's Kyleena ( … .S. Food and Drug Administration (FDA) approved Kyleena (levonorgestrel-releasing intrauterine system … Posted: September 2016 Kyleena (levonorgestrel) FDA Approval History View comments

… US Food and Drug Administration (FDA) approved the labeling update of … . at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch). Please see …

… , at Food and Drug Administration (FDA) i USA har godkendt en …

… .S. Food and Drug Administration (FDA) has approved AMJEVITA(TM) (adalimumab-atto … adalimumab biosimilar approved by the FDA and has been approved for …

By , Last Updated: Friday, September 23, 2016 WASHINGTON --  (AP) Federal regulators have approved the first alternative version of the second-biggest selling drug in the world, AbbVie's Humira, a blockbuster injection used to treat rheumatoid …

FDA Launches Competition to Help Reduce … an overdose with help The FDA has announced the 2016 Naloxone … overdose. This builds on the FDA’s Opioids Action Plan, designed … administer the life-saving medication,” said FDA Commissioner Robert M. Califf, M …

REUTERS/Karoly Arvai The FDA just approved a version of … patients with serious medical conditions,” FDA director Janet Woodcock said in … a biologic-license application to the FDA for its version of pegfilgrastim …

Drugmakers to remove incentives for sales reps marketing antibiotics; Mylan CEO defends EpiPen pricing; fitness trackers don't help people lose weight Sales reps are now more likely to engage with physicians through nonpersonal promotion than …

… .S. Food and Drug Administration (FDA) to market NATRELLE INSPIRA® Cohesive … , form-stable gel.1-3" The FDA approval of NATRELLE INSPIRA® Cohesive … responsive gel was approved by FDA in February 2015, and the … the timing or outcome of FDA approvals or actions, if any …

… to be approved by the FDA and is expected to be … counterparts, biosimilars approved by the FDA to date are not considered … are not called generic. The FDA has determined, however, that there …

WASHINGTON (AP) — Federal regulators have approved the first alternative version of the second-biggest selling drug in the world, AbbVie's Humira, a blockbuster injection used to treat rheumatoid arthritis and other inflammatory diseases. The Food and …

… , Allergy and Rheumatology Products in FDA’s Center for Drug Evaluation … East Hanover, New Jersey. The FDA, an agency within the U …