Summary : Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the…
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Tag:
Approval
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RegulatoryU.S FDA
GC Pharma Receives Complete Response Letter From the U.S. FDA For ‘ALYGLO’
by adminby adminSummary : GC Pharma (KRX:006280) today announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug…
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Summary : One of Eli Lilly’s diabetes drugs just scored another win with the U.S. Food and Drug Administration to expand its…
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AstraZenecaCovid DrugsRegulatoryU.S FDA
FDA Adjusts EUA Dosing On Evusheld To Fight Omicron
by adminby adminSummary: The U.S. Food and Drug Administration (FDA) has revised its emergency use authorization (EUA) for AstraZeneca’s Evusheld to a higher dose…
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Summary : The U.S. Food and Drug Administration has accepted Mirati Therapeutics’ New Drug Application (NDA) for its candidate drug for non-small cell lung cancer (NSCLC). The…
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CompaniesCovid DrugsPfizer
Pfizer Postpones EUA in Kids Under 5, will Wait for Full Data
by adminby adminSummary – -On the day the public and members of the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory…
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436 RC meetingCIBRC - Indian Pesticide ApprovalsRC Meeting updates
INDIAN PESTICIDE APPROVAL UPDATES: 436th RC MEETING [CIBRC]
by adminby adminMINUTES OF THE 436th REGISTRATION COMMITTEE MEETING HELD ON 28.01.2022 The 436th meeting of the Registration Committee (RC) was held under the…
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RegulatoryU.S FDA
FDA Investigating Possible Death Risk Linked to TG Therapeutics’ Lymphoma Drug
by adminby adminSynopsis: The U.S. Food and Drug Administration announced it is investigating a possible death risk for TG Therapeutics’ Ukoniq (umbralisib). The drug…
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Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine;…
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Global MarketRegulatoryU.S FDA
FDA, NIH, and 15 private organizations join forces to increase effective gene therapies for rare diseases
by adminby adminSynopsis : The U.S. Food and Drug Administration, the National Institutes of Health, 10 pharmaceutical companies and five non-profit organizations have partnered…