FDA Grants EUA for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Novavax’s adjuvanted Covid-19 vaccine, NVX-CoV2373, as
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Regulatory
AstraZeneca’s Liver Cancer Treatment Combo Accepted for US Priority Review
Tremelimumab, in conjunction with Imfinzi, has been accepted under priority review for patients with unresectable liver cancer in the United
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FDA Approves Bristol Myers’ Opdualag for Unresectable or Metastatic Melanoma
American multinational pharmaceutical company Bristol Myers Squibb has announced that OpdualagTM , a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as one intravenous infusion,
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Moderna’s ‘Spikevax’ COVID-19 Vaccine Gets Full FDA Approval
The U.S. Food and Drug Administration (FDA) has approved a second COVID-19 vaccine developed by Moderna, which will be marketed
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Abecma Becomes the First CAR T Cell Therapy Approved for Multiple Myeloma in Japan
Based on data obtained from Phase II and the Phase I studies, Abecma has received approval in Japan for the
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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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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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