Here is a recap of every FDA approval announced by the regulatory agency in the month of April, spanning various cancer types ...

The U.S. Food and Drug Administration this week granted permission for the use of a new cancer drug from China despite ...

Akeso, a Chinese biotech that made headlines for beating Merck’s Keytruda in a head-to-head trial, won approval in China this ...

The FDA has granted approval to treatment with Tepylute, a ready-to-dilute version of thiotepa, at 100 mg for breast and ...

TLX101-CDx is an investigational positron emission tomography agent that targets the membrane transport proteins, LAT1 and LAT2.

The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...

Zevaskyn, which Abeona priced at $3.1 million, treats epidermolysis bullosa. It will compete with a gene therapy from Krystal ...

The time between accelerated approval and first reporting of negative confirmatory trial results ranged from 1 year to more than 9 years. There may be “substantial delays” between when a drug ...

Penpulimab is approved for multiple indications in China, but this marks the first US approval for the novel monoclonal ...

There is currently no FDA-approved targeted amino acid PET agent for brain cancer imaging available in the US. TLX101-CDx was previously granted Orphan Drug and Fast Track designations by the FDA.