The FDA said the recall was classified as the most serious Class 1 type, where there is a probability of serious health problems or death.» Read More
The U.S. Food and Drug Administration warned that popular acne products can cause rare but serious and life-threatening allergic reactions.
June 25- The U.S. Food and Drug Administration warned on Wednesday that popular acne products such as Proactiv and Neutrogena can cause rare but serious and life-threatening allergic reactions.
WASHINGTON, June 24- A GlaxoSmithKline Plc plant in Canada that makes the flu vaccine Flulaval has been cited by the U.S. Food and Drug Administration for failing to meet quality control standards.
WASHINGTON, June 24- The U.S. Food and Drug Administration has warned GlaxoSmithKline Plc that one of its plants in Canada violated quality control standards during the manufacture of its influenza vaccine Flulaval.
June 24- The U.S. Food and Drug Administration said an unit of GlaxoSmithKline Plc violated quality requirements during the manufacture of influenza vaccine Flulaval. In a warning letter, the FDA said the company had failed to take appropriate steps to prevent microbiological contamination of drugs, among other violations.
Michael Bonney, Cubist Pharmaceuticals CEO, discusses the FDA's approval of Sivextro, a new antibiotic designed to treat skin infections. Bonney also explains why so many pharma companies have left the antibiotic space.
June 23- AstraZeneca Plc's experimental ovarian cancer drug, olaparib, showed an 83 percent reduction in the risk of disease progression, but a U.S. Food and Drug Administration staff review has questioned whether the result could be reproduced.
Genetics startup 23andMe said it is one step closer to resuming sales of its full-fledged health product.
The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia.
June 18- EnteroMedics Inc's shares jumped about 37 percent in premarket trading on Wednesday, a day after an advisory panel to the U.S. Food and Drug Administration voted in favor of the company's device to treat obesity.
The letter, dated June 16, referenced an FDA inspection that took place in January at the company's facility in Bangalore, India, where inspectors found significant deviations from good manufacturing practices. "If the results obtained were atypical, a fresh sample was to be prepared and analyzed," the FDA said in its letter.
WASHINGTON, June 17- The U.S. Food and Drug Administration on Tuesday issued proposed guidelines for the pharmaceutical and medical device industries for posting information on social media networks and correcting misinformation posted by others. To illustrate, the FDA provided the example of a hypothetical memory loss drug, NoFocus.
June 13- U.S. regulators have granted priority review for AbbVie Inc's experimental all-oral regimen for patients infected with the most common genotype of hepatitis C virus, the company said on Friday. AbbVie said it had submitted in May marketing applications for regulatory approval in the European Union.
WASHINGTON, June 12- Shire Plc has agreed to a U.S. Food and Drug Administration request to study its stimulant Vyvanse in preschool children as concern rises over the diagnosis and treatment of attention deficit hyperactivity disorder, the drugmker said on Thursday.
WASHINGTON, June 12- An advisory committee to the U.S. Food and Drug Administration recommended on Thursday that the agency not require large cardiovascular safety trials for a class of drugs used to treat opioid-induced chronic constipation.
POM Wonderful may take Coke to court to accuse it of misleadingly marketing one of its Minute Maid juices, the U.S. Supreme Court said.
June 12- Geron Corp said the U.S. Food and Drug Administration lifted a partial clinical hold on a study testing its drug for myelofibrosis, a type of blood cancer, sending its shares soaring about 31 percent in premarket trading. Patient enrollment in the trial, sponsored by Mayo Clinic, was halted in March over concerns of liver toxicity.
June 12- Geron Corp said the U.S. Food and Drug Administration lifted a partial clinical hold on a study testing its blood cancer drug, imetelstat, sending its shares soaring about 34 percent in premarket trading. Patient enrollments in the trial, sponsored by Mayo Clinic, were halted in March over concerns of liver damage.
June 11- Orexigen Therapeutics Inc said the U.S. Food and Drug Administration delayed a decision on the marketing application for its obesity drug by three months, sending the company's shares down about 19 percent in premarket trading.
June 11- Orexigen Therapeutics Inc said the U.S. Food and Drug Administration delayed its decision on the marketing application of its obesity drug, contrave, by three months, sending its shares down about 12 percent in premarket trading.