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
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 : SOLOSEC® demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on a landmark Phase 3…
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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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AgrochemicalsFenofibrate
Lupin Launches Authorized Generic Version of Antara (Fenofibrate) Capsules in the United States.
by adminby adminKEYPOINTS: The product is a generic version of the Lupin Atlantis Holdings, S A Corporation’s Antara capsules Fenofibrate Capsules (RLD: Antara Capsules)…
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