RAPS

FDA Finalizes Accelerated Approval Labeling Guidance

The US Food and Drug Administration (FDA) on Tuesday finalized guidance on labeling drugs and biologics approved under the accelerated approval pathway. FDA's accelerated approval program allows the ...
RAPS

FDA Releases New Accelerated Approval Labeling Guidance

A new guidance document published by the US Food and Drug Administration (FDA) is intended to clarify how drugs approved through the accelerated approval pathway should be labeled. FDA's accelerated ...
Nasdaq

Roche announces FDA approval of label expansion into biliary tract cancer

Roche (RHHBY) announced the FDA approval of a label expansion into biliary tract cancer, or BTC, for the Pathway anti-HER2/neu Rabbit Monoclonal Primary Antibody test. This test is now the first and ...
Hosted on MSN

J&J gains label expansion approval for Akeega in mCSPC

Johnson & Johnson (J&J) has secured a US label expansion for its next-generation oncology combination, Akeega, in breast cancer gene 2 (BRCA-2)-mutated, metastatic, castration-sensitive prostate ...
The National Law Review

Krystal Biotech Announces FDA Approval of Updated VYJUVEK® Label

PITTSBURGH, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) approved a label update ...