Synopsis: Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and…
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RegulatoryU.S FDA
Alymsys® (Bevacizumab-maly), a Biosimilar of Bevacizumab developed by mAbxience, has been Approved by the FDA.
by adminby adminSummary : ALYMSYS® was developed by mAbxience, a global biotech company with over a decade of experience in the development, manufacture, and commercialization…
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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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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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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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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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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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