Johnson & Johnson JNJ announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion for the expanded use of the ...

(RTTNews) - AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and ... are currently under review in Japan and several other countries ...

has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted indications are for add-on maintenance treatment of asthma in ...

The European Commission, which grants central marketing authorizations in the European Union (EU), will review the ... Based on the positive CHMP opinion, Bavarian Nordic will now also submit a ...

ImmunityBio (IBRX) announced the European Medicines Agency has accepted for review and begun assessing the marketing authorization application for Anktiva in combination with Bacillus Calmette ...

GSK (GSK) announced that the European Medicines Agency, EMA, has accepted for review the Marketing Authorisation Application, MAA, for the use of depemokimab in two indications. The submitted ...

The Scientific Advisory Group (SAG) has been called in to assist the EMA’s CHMP human medicines committee in its review of the drug, which is vying to become the first disease-modifying therapy ...

The Committee for Medicinal Products for Human Use (CHMP) has recommended that the immunotherapy be approved to treat adults with limited-stage small cell lung cancer (SCLC) whose disease has not ...

A reconciliation of Net income available for MAA common shareholders to FFO and Core FFO, and discussion of the components of FFO and Core FFO, can be found later in this release. FFO per Share ...

Our critic A.O. Scott marvels at the power and paradox of a sonnet by Gwendolyn Brooks. By A.O. Scott Suggested reading from critics and editors at The New York Times. In “All or Nothing ...

Tecvayli (teclistamab) is an off-the-shelf bispecific antibody targeting both BCMA and CD3 which is also under review at the FDA ... lung cancer (NSCLC). The CHMP has backed approval of Tecvayli ...

The Committee for Medicinal Products for Human Use (CHMP) has recommended that Capvaxive be used to ... The European Commission (EC) will now review the positive opinion as it makes a final decision ...