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10 years after a rejection, Merck returns to the FDA with a Gardasil 9 age expansion bid fiercevaccines
July 23, 2018
How long is a drugmaker willing to wait on an indication expansion plan? For Merck’s HPV vaccines, that's 10 years.
FDA chief Gottlieb blames drugmakers for ‘anemic’ biosimilar market fiercepharma
July 23, 2018
The FDA has so far approved 11 biosimilars, drugs that should be saving patients billions of dollars. But so far, only three of the 11 have made it to the market in the U.S., a fact FDA Commissioner Scott Gottlieb, M.D., is blaming on the reference drugma
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation pharmatimes
July 23, 2018
The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation.
Cell-based flu vaccines only slightly better than traditional shots in seniors: FDA study fiercevaccines
July 23, 2018
Recent studies have blamed the egg-based vaccine production process for less effective flu shots. But flu vaccines made from the newer, cell-based technology didn't perform much better in seniors last year either, a new FDA report finds.
Kisqali wins speedy US breast cancer nod pharmatimes
July 20, 2018
Novartis’ Kisqali has been approved for breast cancer in the US less than one month after being filed with the US Food and Drug Administration.
FDA approves the first drug with an indication for treatment of smallpox europeanpharmaceuticalreview
July 19, 2018
The US Food and Drug Administration has approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox…
FDA approves Calcitriol’s new contract manufacturing submission biospectrumasia
July 18, 2018
This approval was necessary in order to market and commercialize Calcitriol in the United States.
Pfizer halts production at India injectables plant after FDA again finds issues fiercepharma
July 18, 2018
Pfizer has again suspended production at a long-troubled sterile injectables plant in India that the FDA has twice before cited for manufacturing and testing issues.
With FDA nod, Pfizer and Astellas’ Xtandi gets its shot at blockbuster sales boost fiercepharma
July 17, 2018
Pfizer and Astellas have their chance to bring Xtandi to prostate cancer patients before their disease has spread through the body.
FDA joins EU in seeking recall of certain Chinese-made valsartan products over potential cancer risk fiercepharma
July 17, 2018
Recalls of certain drugs containing heart drug valsartan supplied by Zhejiang Huahai Pharmaceutical have spread to the U.S., as the FDA sought voluntary actions to take some affected drugs off the shelves due to the potential cancer risk.

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