Drug Trials Snapshots: MODEYSO
Drug Trials Snapshots: MODEYSO
FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer
On November 19, 2025, the Food and Drug Administration granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen Inc.) for adults with…
FDA grants accelerated approval to sevabertinib for non-squamous non-small cell lung cancer
On November 19, 2025, the Food and Drug Administration granted accelerated approval to sevabertinib.
Questions and Answers: FDA posts deemed final order and proposed order for over-the-counter sunscreen
The following questions and answers provide more information on the deemed final order and proposed order.
FDA grants traditional approval to daratumumab and hyaluronidase-fihj for newly diagnosed light chain amyloidosis
On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech…
FDA Modernizes Clinical Trials with Master Protocols
“FDA Modernizes Clinical Trials with Master Protocols” February 26, 2019 Issue
FDA approves selumetinib for adults with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
On November 19, 2025, the Food and Drug Administration approved selumetinib (KOSELUGO, AstraZeneca Pharmaceuticals LP) for adults with neurofibromatosis type…
Drug Trials Snapshots: ANZUPGO
Drug Trials Snapshots: ANZUPGO
PEth Cut‐Off Thresholds for Hazardous Alcohol Consumption Based on a Drinking Study
PEth 16:0/18:1 and 16:0/18:2 concentrations in voluntary participants taking part in a 2-week drinking study with intake of one or…
CDER SBIA Chronicles
FDA/CDER SBIA Chronicles, the bi-monthly newsletter of the CDER Small Business and Industry Assistance team, provides industry with useful information…