The FDA approves Emergent BioSolutions' sBLA seeking a label expansion of ACAM2000 for the mpox indication. Stock rises in pre-market trading.

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

The approval expands the label of TVTX's Filspari in IgAN indication. However, the label also comes with a boxed warning for liver problems and...

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for lofexidine...

Indoco Remedies Limited (Indoco) announced the receipt of final approval from the US FDA for Abbreviated New Drug Application (ANDA) for lofexidine...

Spring House, Pa. (August 29, 2024) – Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and...

The Food and Drug Administration (FDA), as many are aware, is the leading entity for the regulation and safety testing for foods and pharmaceuticals...

The Nigerian government through the Securities and Exchange Commission (SEC) has granted approval in principle to two cryptocurrency firms, Busha...

The Nigerian government through the Securities and Exchange Commission (SEC) has granted approval in principle to two cryptocurrency firms, Busha...

EBR Systems has submitted the final premarket approval (PMA) application module to the US Food and Drug Administration (FDA) for ...