Summary: The World Health Organization (WHO) has awarded prequalification to Mosquirix, GSK’s malaria vaccine. This is the first prequalification for a malaria vaccine…
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Tag:
Vaccine
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AstraZenecaRegulatoryU.S FDA
ENHERTU® Approved in the U.S. as the First HER2 Directed Therapy for Patients with HER2 Low Metastatic Breast Cancer
by adminby adminSynopsis: 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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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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CompaniesCovid DrugsPfizer
Pfizer and BioNTech receive expanded U.S. emergency use authorization for an additional COVID-19 vaccine booster in individuals aged 50 years and older
by adminby adminSummary: Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has expanded…
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CompaniesCovid DrugsPfizer
Pfizer and BioNTech aubmit for U.S. Emergency Use Authorization of an additional booster dose of their COVID-19 vaccine for older adults
by adminby adminSummary : Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced the companies have submitted an application to the U.S. Food…
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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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Synopsis : Pfizer Inc. (NYSE: PFE) Pfizer stands with the unified global community across the public, private and civil society sectors in…
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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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