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

Nearly 70% of cancer drugs granted FDA accelerated approval between 2011 and 2020 required safety updates within 4 years.“Postmarketing safety actions are common,” Maryam Mooghali, MD, MSc, internal ...

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 ...

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 ...

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

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 ...

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 ...

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, ...

Amgen (AMGN) and AstraZeneca (AZN) are approaching a potential catalyst event on October 19, when the FDA will rule on Tezspire for treating chronic rhinosinusitis with nasal polyps (CRSwNP). If ...

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 ...