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Government Agencies FDA

  • LONDON, March 31- Philip Morris International said on Friday it has applied for pre-market approval of its iQOS heated tobacco product with the U.S. Food and Drug Administration. The world's largest international tobacco maker, owner of the Marlboro brand, said that if the FDA grants its request, its U.S. affiliate, Altria Group, would be responsible for selling...

  • UK- based Oxford BioMedica's shares get a lift. ZURICH, March 30- A new leukaemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration, putting the Swiss drugmaker ahead of rivals working on similar cancer therapies. The FDA's announcement late Wednesday means the regulator plans to take...

  • *UK- based Oxford BioMedica's shares get a lift. ZURICH, March 30- A new leukemia treatment from Novartis for children and young adults will get priority review from the U.S. Food and Drug Administration, putting the Swiss drugmaker ahead of rivals working on similar cancer therapies. The FDA's announcement late Wednesday means the regulator plans to take action...

  • Scott Gottlieb, President Donald Trump's nominee to lead the U.S. Food and Drug Administration, has outlined measures he would take to untangle his ties to the pharmaceutical industry if confirmed by the Senate. In an ethics disclosure form filed with the Department of Health and Human Services on Tuesday, Gottlieb said he would resign from multiple corporate...

  • March 29- Mylan NV said on Wednesday the U.S. Food and Drug Administration declined to approve its generic version of GlaxoSmithKline Plc's blockbuster Advair asthma treatment, but provided no details of the agency's concerns or how long the product might be delayed. Mylan said it received a so-called complete response letter from the FDA, which had been...

  • March 29- Mylan NV said on Wednesday its application to market a generic copy of GlaxoSmithKline Plc's blockbuster inhaled lung drug Advair was rejected by the U.S. Food and Drug Administration. The FDA was expected to decide by Tuesday whether to approve the first substitutable generic copy of Advair, a two-part drug used to treat asthma and chronic lung...

  • March 29- Mylan NV said on Wednesday its application to market a generic copy of GlaxoSmithKline Plc's blockbuster inhaled lung drug Advair was rejected by the U.S. Food and Drug Administration. The drugmaker did not disclose the reason behind the rejection. Advair has generated more than $1 billion in annual sales since 2001..

  • Scott Gottlieb, President Donald Trump's nominee to lead the U.S. Food and Drug Administration, has outlined measures he would take to untangle his ties to the pharmaceutical industry if confirmed by the Senate. In an ethics disclosure form filed with the Department of Health and Human Services on Tuesday, Gottlieb said he would resign from multiple corporate...

  • ZURICH, March 29- Roche's multiple sclerosis drug Ocrevus won U.S. approval, putting the potential blockbuster back on track after a brief delay and giving a lift to patients with a form of the disease that until now had no approved treatment. The drug, also known as ocrelizumab and administered via infusion, becomes the first U.S. Food and Drug Administration-...

  • LONDON, March 29- A deadline for U.S. regulators to give a verdict on a generic copy of GlaxoSmithKline's blockbuster inhaled lung drug Advair has passed with no sign of approval, sparking speculation that a threat to GSK profits might be delayed. The U.S. Food and Drug Administration had been due to decide by March 28 whether to approve the first substitutable...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Roche Holding AG's multiple sclerosis drug Ocrevus, putting the potential blockbuster drug back on track after a delay caused by regulators' concerns over manufacturing issues. Roche said Ocrevus will be available to people in the United States within two weeks. The drug's entry into the U.S....

  • LONDON, March 29- GlaxoSmithKline shares gained on Wednesday as lack of news about U.S. approval of a generic copy of its blockbuster inhaled lung drug Advair buoyed speculation that a threat to profits might be delayed. The U.S. Food and Drug Administration had been due to decide by March 28 whether to approve the first substitutable generic copy of the two-part...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Roche Holding AG's multiple sclerosis drug Ocrevus, putting the potential blockbuster drug back on track after a delay caused by regulators' concerns over manufacturing issues. Roche said Ocrevus will be available to people in the United States within two weeks. The most popular MS treatment...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Roche Holding AG's multiple sclerosis drug Ocrevus, putting the potential blockbuster drug back on track after a delay by regulators over manufacturing issues. The drug's entry into the U.S. market was delayed by three months when the FDA in late December pushed back its deadline for an...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Roche Holding AG's multiple sclerosis drug Ocrevus, putting the potential blockbuster drug back on track after a delay by regulators over manufacturing issues. The injectable drug, known chemically as ocrelizumab becomes the first U.S. approved medicine for primary progressive form of the...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA's drug for moderate-to-severe atopic dermatitis, a product widely seen as the most important growth driver for the two companies. Wall Street analysts forecast annual sales exceeding $4 billion by 2022 for the biotech drug known chemically as...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA's drug for moderate-to-severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies. Wall Street analysts forecast annual sales exceeding $4 billion by 2022 for the biotech drug known...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA's Dupixent for treatment of moderate to severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies. The drug will have a list price of $37,000 a year, Sanofi said. Wall Street analysts forecast...

  • March 28- The U.S. Food and Drug Administration on Tuesday approved Regeneron Pharmaceuticals Inc and Sanofi SA's Dupixent for treatment of moderate to severe atopic dermatitis, a product widely seen as the most important future growth driver for the two companies.

  • March 27- The U.S. Food and Drug Administration on Monday approved Tesaro Inc's key drug, niraparib, for the treatment of recurrent ovarian cancer. The U.S. biopharmaceutical company's shares were up 7.78 percent at $168.9 in extended trading. Tesaro expects to launch niraparib in the United States in late April.