Summary: The World Health Organization (WHO) has awarded prequalification to Mosquirix, GSK’s malaria vaccine. This is the first prequalification for a malaria vaccine…
who
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Global MarketRegulatoryU.S FDA
Sol-Gel Technologies and Galderma’s EPSOLAY® Scores US FDA Approval
by adminby adminSummary: EPSOLAY (benzoyl peroxide, cream, 5%) utilizes Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions of rosacea and is patent…
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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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AstraZenecaRegulatoryU.S FDA
FDA says no to AZ’s Fasenra for nasal polyp indication
by adminby adminSummary : AstraZeneca has failed in its bid to get US approval for its IL-5 inhibitor Fasenra as a treatment for chronic…
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AstraZenecaPharma Science & Research
First RSV vaccine trial for infants offers significant results
by adminby adminSummary : Results from a phase 3 trial evaluating AstraZeneca and Sanofi’s jointly developed treatment nirsevimab – the first investigational long-acting antibody, designed to protect…
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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…