The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...

specifically in comparing approval regulatory cycles for the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Last year we wrote a three-part series, "Life in the Fast ...

Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with ...

The committee's recommendation was based on data from the TROPION-Breast01 trial, which also supported the US approval of Datroway in January.

Ocugen, Inc. (NASDAQ: OCGN) has reached a significant milestone in the development of its gene-agnostic therapy, OCU400, as the European Commission has delivered a positive opinion designating it ...

I'd start with Aaron Glenn,' Parcells told him." If a head coaching legend of Parcells' caliber gave his stamp of approval for Glenn, that should be an exciting sign for the team.

three years after surrendering the approval. The reinstatement of the Easa Part 145 certification by the European Aviation and Safety Agency affirms KQ’s ability to maintain and repair aircraft ...

Japanese floater expert Modec and Toyo Engineering Corporation have obtained approval in principle from the American Bureau of Shipping (ABS) for a blue ammonia FPSO. This FPSO is intended to ...

The FDA said some of the most common side effects reported among study participants include itching, muscle spasms and rash. The last time the agency approved a new painkiller was in 1998.