With this latest approval, JNJ's Tremfya is approved for a total of three immunology indications.

With this latest approval, JNJ's Tremfya is approved for a total of three immunology indications.

InspireMD announces the submission of the PMA application to the FDA for marketing approval of the CGuard Prime EPS.

REGN gets FDA nod for Dupixent for a broader population for the indication of chronic rhinosinusitis with nasal polyps.

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...

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...

The FDA approves NVS' Kisqali to reduce the risk of disease recurrence in patients with HR+/HER2- early breast cancer.

Boston Scientific received FDA approval on the expanded indication for INGEVITY+ Pacing Leads. Data demonstrated this lead to be safe and effective...