In a decision not everyone anticipated, the EU’s drugs regulator, European Medicines Agency, EMA, announced on Oct. 4 it was authorizing a booster shot of the Pfizer...

Acting quickly after its advisory panel published its guidance, the US Food and Drug Administration (FDA) on Sept. 22 announced it was amending its Emergency Use...

The US plans to more than double its commitment to donate Covid-19 vaccines to the developing world, President Joe Biden announced on Sept. 22 at a virtual vaccine summit...

Phase 2/3 clinical trials with the Pfizer/BioNTech Covid-19 vaccine Comirnaty have shown that it is safe, well tolerated and produces robust neutralizing antibody...

Digital tools are a key to shortening the development of active pharmaceutical ingredients and thus market-ready drugs and therapies.

Two key vaccine officials of the US Food and Drug Administration (FDA) plan to quit the agency over the next three months in protest against President Joe Biden’s plan to...

Pfizer and BioNTech, partners in developing, producing and marketing the Covid-19 vaccine now called Comirnaty, have sealed a deal with CDMO Eurofarma Laboratories of...

US biotech Moderna announced on Aug. 26 that it had completed its filing with the US Food and Drug Administration (FDA) for full marketing approval of its mRNA-based...