FDA Approvals

There is currently no cure for cystic fibrosis (CF), a debilitating, progressive condition with over 10,830 people in the UK currently diagnosed with the...

New lung cancer treatment combo approved on NHS in England

FDA Approvals

A new treatment for some people with a type of non small cell lung cancer (NSCLC) will now be routinely available on the NHS...

Pfizer and BioNTech Receive U.S. FDA EUA of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

FDA Approvals

Pfizer Inc. and BioNTech SE announced that the U.S. FDA has expanded the EUA of a booster dose of the Pfizer-BioNTech COVID-19 Vaccine to...

WuXi STA’s Shanghai Facility Gets FDA Nod Post Inspection

FDA Approvals

WuXi AppTec’s WuXi STA has said that its facility at Waigaoqiao near Shanghai has cleared its first FDA drug product pre-approval inspection. Notably, the...

WuXi STA Passes the First U.S. FDA Drug Product Pre-Approval Inspection at its Shanghai Waigaoqiao site

FDA Approvals

WuXi STA – a subsidiary of WuXi AppTec, announced that its Waigaoqiao site in Shanghai, China, successfully passed the first drug product pre-approval inspection...

FDA clears AstraZeneca’s Covid antibody treatment for immunocompromised

FDA Approvals

The FDA authorized the first injectable monoclonal antibody cocktail for long-term prevention of Covid-19 among people with weakened immune systems before they have been...

Actemra/RoActemra approved by the European Commission to treat patients with severe COVID-19

FDA Approvals

Roche announced that the European Commission has extended the marketing authorisation for Actemra®/RoActemra® (tocilizumab) to include the treatment of COVID-19 in adults who are...

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