Pfizer’s COVID-19 Antiviral PAXLOVID Approved by UK Regulator
Pfizer’s COVID-19 Antiviral, PAXLOVID, has been authorised for use in people over 18 with mild to moderate COVID-19 and at
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Regulatory
AstraZeneca’s Evusheld Becomes First FDA Authorised Antibody Therapy to Prevent COVID-19
Evusheld, a long-acting antibody (LAAB) combination from AstraZeneca, has received emergency use authorisation (EUA) by the FDA in the United
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First Oral COVID-19 Antiviral Medicine Approved in the UK
Merck and Ridgeback’s Molnupiravir has become the world’s first approved oral COVID-19 antiviral drug. Molnupiravir has been authorised by the
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FDA Panel in Favor of Pfizer’s COVID-19 Vaccine for Children Aged 5 to 12
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted 17 to 0,
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EC Approves Merck’s KEYTRUDA® for Triple-Negative Breast Cancer
KEYTRUDA® has been granted approval as a first-choice treatment in combination with chemotherapy for patients with locally recurrent unresectable or
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FDA Expands Use of COVID-19 Vaccine Booster Dose in Eligible Populations
The US Food and Drug Administration has granted approval for administration of COVID-19 vaccine booster dosage, upgrading the emergency use
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Genentech’s Investigational Antibody Wins BTD for Alzheimer’s Treatment
Genentech’s investigational antibody for the treatment of early-stage Alzheimer’s disease, Gantenerumab, has been granted Breakthrough Therapy Designation by the U.S.
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Tezepelumab gets ODD in the US for Eosinophilic Esophagitis
Tezepelumab, developed by AstraZeneca in collaboration with Amgen, has been granted Orphan Drug Designation (ODD) in the US FDA for
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WHO Endorses GlaxoSmithKline’s Breakthrough Malaria Vaccine
The World Health Organization on Wednesday endorsed the groundbreaking GlaxoSmithKline Malaria vaccine for children at risk reinvigorating the fight against
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FDA OK’s Tecartus® CAR T-cell Therapy for B-cell Acute Lymphoblastic Leukemia
Kite Pharma, a Gilead Company, announced on Friday that the U.S. FDA has granted approval for CAR T-cell therapy Tecartus®
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