Glenmark Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has put its manufacturing plant located at Baddi, India, under import alert. The drugs manufactured at Glenmark Pharmaceuticals at Baddi plant can now be detained without any physical examination. The US FDA inspected the facility in June 2022, and has subsequently placed it […]
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The US FDA approved the new tablet formulation of Calquence by AstraZeneca in the United States for all current indications, including patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL), and patients with relapsed mantle cell lymphoma. The approval by the US FDA was based on results from the ELEVATE-PLUS trials presented at the […]
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Officials of the Food and Drug Administration (FDA) of the United States said that, the agency has been aiming to decide that, whether to change the design of the novel corona virus vaccines or not by June 2022 in order for combating the future variants of the novel corona virus even if the US FDA […]
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The company ‘Esaote North America, Inc.’ has announced the approval from the US FDA of the Magnifico Open MRI, which has been a complete body MRI system that is now available for the purchase in the United States. The Magnifico Open MRI system had been designed with the users in the mind through the feedback […]
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The two pills, especially Paxlovid pill developed by Pfizer, has now been seen as the most promising new oral treatments, which can possibly be taken on the onset of the symptoms at the homes of the people for the purpose of providing help in preventing the hospitalizations and deaths related to the novel corona virus […]
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Takeda Pharmaceutical has announced that, the US FDA has given the approval to the Livtencity (maribavir) drug for the purpose of treating the adults and the pediatric patients suffering from the post-transplant CMV infection that is having a refractory to the treatment with ganciclovir, cidofovir, foscarnet or valganciclovir. More than double the proportion of the […]
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Pfizer and BioNTech are seeking for the emergency use authorization (EUA) from the US FDA for a third dose of the company’s mRNA vaccine for all the adult population in the United States. The US FDA is also going to consider the request with reconvening an expert panel, as it had been done in the […]
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The company ‘Oyster Point Pharma Inc.’ said, the US FDA has now approved the Tyrvaya varenicline solution nasal spray 0.03 mg for the treatment of the symptoms and signs of the dry eye disease, and the company also said, the Tyrvaya nasal spray has been the first and only nasal spray, that has been approved […]
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On Friday, 8th October 2021, the company ChemoCentryx Inc., said, the health agency of the United States has given the authorization to the company’s lead drug for the treatment of a rare and fatal autoimmune disease, that has been sending the shares of the biopharmaceutical company up by more than 70 percent. Thomas Schall, chief […]
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The pharmaceutical company ‘Lilly’ said that, the Food and Drug Administration (FDA) of the United States had widened the emergency use authorization for the baricitinib for the purpose of allowing it for the treatment of the novel corona virus with or without the remdesivir. The previous emergency use authorization had been restricted for using it […]
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