FDA Approvals

The US FDA gives a green signal to Pfizer-BioNTech COVID-19 vaccine as it declairs it to be safe and effective. A US roll-out of...

FDA authorizes monoclonal antibodies for treatment of COVID-19

FDA Approvals

FDA issued an EUA for casirivimab and imdevimab (Regeneron Pharmaceuticals) to be administered together for the treatment of mild to moderate COVID-19 in adults...

Moderna Announces the EC’s Approval of Advance Purchase Agreement for Initial 80 Million Doses of mRNA Vaccine Against COVID-19

FDA Approvals

Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that...

Catalent Signs Commercial Supply Agreement with Blueprint Medicines Following FDA Approval of GAVRETO

FDA Approvals

Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products,...

Novavax COVID-19 Vaccine Granted Fast Track Designation by U.S. FDA

FDA Approvals

Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced that the U.S. FDA has granted Fast Track Designation for...

EC approves Roches Tecentriq in combination with Avastin for the treatment of people with the most common form of liver cancer

FDA Approvals

Roche announced that the European Commission has approved Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab) for the treatment of adult patients with advanced or...

U.S. FDA Approves Gileads Antiviral Veklury (remdesivir) for Treatment of COVID-19

FDA Approvals

Gilead Sciences, Inc. announced that the U.S. FDA has approved the antiviral drug Veklury for the treatment of patients with COVID-19 requiring hospitalization. As...

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