FDA Approvals

Celltrion’s regdanvimab becomes the first authorized COVID-19 treatment approved from the Korean MFDS

20th September 2021

Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) approved regdanvimab (CT-P59), a monoclonal antibody treatment...

UK MHRA approves one-dose Janssen Covid-19 vaccine

by Content Team

7th June 2021

UK MHRA approves one-dose Janssen Covid-19 vaccine

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted regulatory approval for the Janssen’s Covid-19 vaccine. This is...

World Health Organization Authorizes SINOVAC’s CoronaVac for Emergency Use

by Content Team

7th June 2021

World Health Organization Authorizes SINOVAC's CoronaVac for Emergency Use

SINOVAC Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that CoronaVac®, an innovative, inactivated coronavirus vaccine developed...

U.S. FDA confirms Pfizer COVID vaccine safe & effective

by Content Team

9th December 2020

U.S. FDA confirms Pfizer COVID vaccine safe & effective

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

FDA authorizes monoclonal antibodies for treatment of COVID-19

by Content Team

26th November 2020

FDA authorizes monoclonal antibodies for treatment of COVID-19

FDA issued an EUA for casirivimab and imdevimab (Regeneron Pharmaceuticals) to be administered together for the treatment of mild to...

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

by Content Team

26th November 2020

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

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

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

by Content Team

26th November 2020

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

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

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

by Content Team

16th November 2020

FSD Pharma Gets Go Ahead for Phase IIa COVID-19 Trial

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

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

by Content Team

6th November 2020

Roche receives FDA approval for expanded use of the CINtec PLUS Cytology test to aid clinicians in preventing cervical cancer

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