Synopsis: Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and…
covid19
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RegulatoryU.S FDA
FDA approves first generic of Symbicort to treat asthma and COPD
by adminby adminSummary : Today, the U.S. Food and Drug Administration approved the first generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol…
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Summary : As the COVID-19 pandemic continues to claim lives around the world, dairy scientists may have a surprising role to play.…
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RegulatoryU.S FDA
Expert: Newly Appointed FDA Commissioner Robert Califf Is Perfectly Positioned to Advance the FDA’s Accelerated Approval Pathway
by adminby adminSummary : Peter Pitts, a former FDA associate commissioner and president of the Center for Medicine in the Public Interest, discusses the…
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Summary : Several FDA-approved drugs – including for type 2 diabetes, hepatitis C and HIV – significantly reduce the ability of the…
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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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Covid DrugsPharma Science & Research
World’s First Monoclonal Antibody Prequalifies To Treat COVID
by adminby adminSynopsis: In order to increase access to treatments that are recommended to fight COVID-19, the WHO has added a monoclonal antibody treatment…
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Although fractures normally heal, bone will not regenerate under several circumstances. When bone does not regenerate, major clinical problems could result, including…
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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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India
Subject Expert Committee recommends EUA for BE’s Covid jab Corbevax for 12-18 years age group
by adminby adminSummary : The expert panel of India’s central drug authority on Monday recommended granting restricted Emergency Use Authorisation (EUA) to Biological E’s…