FDA drug alerts in pulmonology, including drug approvals/warnings, vaccine approvals, medical device recalls/updates, and ...

Accelerated approval can serve patients well—but only when surrogate endpoints are reliable and clearly predict outcomes that matter to patients.

Sevabertinib received FDA accelerated approval for nonsquamous NSCLC with HER2 TKD mutations, based on the SOHO-01 trial results. Patients naïve to HER2-targeted therapies showed a 71% ORR and a ...

FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...

Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for ...

Delays in diagnosis, long waits for operations may explain trend ...

Poherdy is the first interchangeable biosimilar to Perjeta, approved for HER2-positive breast cancer, expanding access to targeted therapies. Biosimilars like Poherdy meet rigorous FDA standards, ...

Hyrnuo is approved for HER2-mutant NSCLC patients who have received prior systemic therapy, with the Oncomine Dx Target Test as a companion diagnostic. The SOHO-01 trial showed a 71% objective ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...