It's been over 1.5 months since the World Health Organization declared COVID-19 as a pandemic. Due to this public health emergency, the FDA decision on a couple of new drugs has been pushed back several months as many of the regulatory agency's staff is working on COVID-19 activities.
However, the regulatory agency hasn't put off making a decision on drugs proposed for rare tumors and life-threatening diseases in this critical time.
On April 10, Koselugo received the regulatory nod for the treatment of pediatric patients, 2 years of age and older, with neurofibromatosis type 1 (NF1), a genetic disorder of the nervous system causing tumors to grow on nerves. Koselugo, developed by AstraZeneca (AZN), is the first drug approved by the FDA for children with this debilitating and disfiguring rare disease.
On April 15, UroGen Pharma's Jelmyto, the first therapy to treat low-grade upper tract urothelial cancer, was granted FDA approval. Urothelial cancer is a cancer of the lining of the urinary system.
Incyte Corp.'s (INCY) Pemazyre secured accelerated approval on April 17, becoming the first treatment for adults with certain types of previously treated, advanced cholangiocarcinoma, a rare form of cancer in bile ducts that carry the digestive fluid bile from the liver to gallbladder and small intestine.
So far this year, 16 novel drugs have received FDA approval compared to 9 which were greenlighted during the same period last year.
Now, let's take a look at the biotech stocks that are awaiting a regulatory decision in May.
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Business News
December 19, 2025 15:10 ET U.S. inflation data and interest rate decisions by major central banks were the highlights of this busy week for economics news flow. Employment data and survey results on the housing markets also gained attention in the U.S. In Europe, the European Central Bank and Bank of England announced their policy decisions and macroeconomic projections.