Over the past 15 years, 19 drugs have been approved by the FDA to treat sarcomas and 13 by the EMA. Regarding histology, 47% were approved for soft tissue sarcoma, with liposarcoma being the most ...
The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024. On 15 January, the two agencies ...
FDA approves Zyn nicotine pouches, including 10 flavors, as a safer option for adult smokers. The decision marks the first FDA authorization for nicotine pouches, which are tobacco-free.
The FDA approved five fewer novel medicines than in 2023 while the EMA improved its tally by seven. Image credit: Shutterstock / Tamakhin Mykhailo. The US Food and Drug Administration (FDA) has ...
The US Food and Drug Administration approved sotorasib (trade name Lumakras) with panitumumab Vectibix), from US biotech major Amgen (Nasdaq: AMGN), for adult patients with KRAS G12C-mutated ...
The U.S. FDA has approved a novel combination therapy using Lumakras® (sotorasib) and Vectibix® (panitumumab) for adults with KRAS G12C-mutated metastatic colorectal cancer (mCRC). This innovative ...
The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said ...
Companies say they are working to update their products to comply with the Food and Drug Administration's decision ... pose a risk to humans as well. The FDA says that food companies will have ...
The EMA’s human medicines committee recommended 114 medicines for approval in 2024, marking the highest number of positive opinions issued in 15 years ...
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...
The European Medicines Agency (EMA) today revealed that, in 2024, it recommended 114 medicines for marketing authorization. Of these, 46 had a new active substance which had never been authorized in ...