Just as the covid-19 antibody combination of Regeneron known as REGEN-COV has been sidelined in the United States because of the Omicron covid-19 variant, the drug is now facing another delay in getting the approval from the US FDA. The company said that, the Food and Drug Administration (FDA) of the United States has now […]
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Lupin, a pharmaceutical company said, it has now received the approval from the US FDA (Food and Drug Administration) for the purpose of marketing the company’s generic version of Desvenlafaxine extended-release tablets that are used for the purpose of treating depression. The approval granted by the US FDA has been for the abbreviated new drug […]
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The Food and Drug Administration (FDA) of the United States has now approved a fifth corona virus vaccine booster shot developed by the companies including Moderna or Pfizer and BioNTech for the people, who are over 50 years of age and also in some of the immune-compromised individuals. Previously, the US FDA has also authorized […]
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The pharmaceutical company ‘Lupin’ said that, the company has now received an approval from the Food and Drug Administration (FDA) of the United States for the Vigabatrin for the oral solution USP, and the approved ANDA (abbreviated new drug application) has been a generic equivalent of the Sabril for the oral solution of the company […]
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Covaxin, a covid-19 vaccine of Bharat Biotech has now get the approval by the Food and Drug Administration (FDA) of the United States for the clinical trials in the adult people of the United States, and Bharat Biotech said that, the company and the partner ‘Ocugen’ of the US has expressed their commitment towards bringing […]
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The Food and Drug Administration (FDA) of the United States has now rejected for granting the approval for the investigational therapy ‘lenacapavir’ of Gilead Sciences for the treatment of the HIV. The regulatory agency of the United States has also issued a complete response letter (CRL) to the NDA (New Drug Application) of the company […]
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On Monday, 28th February 2022, the company ‘Amryt’ said, the Food and Drug Administration (FDA) of the United States has declined to approve the drug of the company for the treatment of a group of the rare skin diseases called as the epidermolysis bullosa, and the agency has also asked Amryt for the purpose of […]
Continue ReadingThe Strides Pharma Global Pte Limited based in Singapore announced that, it has now received the approval for the Amantadine Hydrochloride Softgel Capsules USP of 100mg from the Food and Drug Administration (FDA) of the United States. The products has been a bioequivalent and therapeutically equivalent to the RLD (reference listed drug) known as the […]
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The company ‘AffaMed Therapeutics’, a clinical stage biotechnology company that is dedicated to the commercialization and development of the transformative pharmaceutical, surgical and digital products announced that, the Food and Drug Administration (FDA) of the United States has now cleared the application of the Investigational New Drug (IND) for the clinical development of the AM712, […]
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The Food and Drug Administration (FDA) of the United States have given the authorization for a new monoclonal antibody treatment that is working effectively against the Omicron covid-19 variant. The emergency use authorization for the bebtelovimab has been for the treatment of the mild to moderate corona virus in the adults and pediatric patients around […]
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