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Yearly Archives: 2020

Tagrisso approved in the US for early-stage EGFR-mutated lung cancer

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December 21, 2020: "AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small...

Roche’s faricimab hits the mark in diabetic macular edema study

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December 21, 2020: "Roche announced positive topline results from two identically designed global phase III studies, YOSEMITE and RHINE, evaluating its investigational bispecific antibody,...

Covaxin: Everything that you should know

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Covaxin is an investigational vaccine candidate for COVID19. It is in Phase III clinical trial as of today (20-Dec-2020). It is being developed by...

FDA Issues Emergency Use Authorization for Second COVID-19 Vaccine

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December 18, 2020: "The U.S. FDA issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19)...

FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer

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December 18, 2020: "The U.S. Food and Drug Administration approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer...

FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer

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December 18, 2020: "The U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.  “Today’s approval marks...

FDA Approves Prosthetic Implant for Above-the-Knee Amputations

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December 18, 2020: "The U.S. Food and Drug Administration approved the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System, the first implant...

Novartis receives complete response letter from U.S. FDA for inclisiran

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 December 18, 2020: The U.S. FDA has issued a complete response letter (CRL) regarding the NDA for inclisiran, a potential treatment for hyperlipidemia in...

GSK and Ahren Announce Co-Led Series A Investment in Adrestia, and Multi-Project Discovery Collaboration

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December 18, 2020: "GlaxoSmithKline and Ahren Innovation Capital announced they will co-lead a Series A investment in Adrestia Therapeutics (“Adrestia”), a UK-based biotechnology company...

COVAX Announces additional deals to access promising COVID-19 vaccine candidates

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December 18, 2020: "COVAX, the global initiative to ensure rapid and equitable access to COVID-19 vaccines for all countries, regardless of income level, today...

Update on US regulatory review of roxadustat in anaemia of chronic kidney disease

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December 18, 2020: "The US FDA has requested further clarifying analyses of clinical data, to complete its review of the NDA for roxadustat, an...

FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

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December 17, 2020: "Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. FDA has informed the sponsor that it...
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