FDA Grants EUA for Two Next-Gen COVID-19 Assays from Thermo Fisher
The global leader in serving science, Thermo Fisher Scientific has announced that the U.S. Food and Drug Administration (FDA) has
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Regulatory
FDA Approves Merck’s VAXNEUVANCE™ Pneumococcal 15-valent Conjugate Vaccine
Merck, also known as MSD, revealed that the U.S. Food and Drug Administration (FDA) has authorised VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate
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Indian Drugmaker Cipla Gets Nod to Distribute Moderna’s COVID Vaccine
The path for India’s first mRNA vaccine import has been cleared with Cipla winning approval to distribute Moderna’s COVID-19 vaccine.
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Genentech’s Actemra Receives FDA Authorization for COVID-19 Treatment
The FDA has granted an Emergency Use Authorization (EUA) which enables the treatment of COVID-19 in hospitalized adult and pediatric
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Pfizer-BioNTech Vaccine Approved in the UK for 12 to 15-year-olds
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the use of the Pfizer-BioNTech vaccine in children aged 12-15
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FDA Issues EUA for GSK & Vir Monoclonal Antibody COVID-19 Treatment
GSK and Vir Biotechnology announced that the monoclonal antibody sotrovimab (VIR-7831) has received Emergency Use Authorization (EUA) from the US
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Single-dose Janssen COVID-19 Vaccine Approved in UK
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has authorized use of the Janssen single-dose COVID-19 vaccine. The
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Pfizer and BioNTech COVID-19 Vaccine Authorised for Adolescents in the U.S.
Pfizer and BioNTech announced that the US Food and Drug Administration (FDA) has authorised their COVID-19 vaccine for adolescents ages
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FDA Approves Injectafer® Single Dose Option for Iron Deficiency Anemia
Injectafer® (ferric carboxymaltose injection) has received approval by the FDA for a single dose option for the treatment of adult
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EC approves XTANDI™ (enzalutamide) for Metastatic Hormone-Sensitive Prostate Cancer
The European Commission has approved Astellas’ XTANDI™ (enzalutamide) for men with metastatic Hormone-Sensitive Prostate Cancer (mHSPC). Japanese multinational pharmaceutical company
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