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

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

The FDA has issued a Complete Response Letter to Telix Pharmaceuticals regarding the NDA for TLX101-CDx for the imaging of gliomas.

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

Zymeworks is rated Strong Buy due to its improved outlook, FDA approval of Ziihera, advancing pipeline, and strong cash position. Zanidatamab (Ziihera) is a key asset with accelerated approval for ...

Last year, the FDA approved the biologic drug Dupixent to treat uncontrolled eosinophilic COPD. The approval marked a step ...

In a phase 3 trial, 81% of wounds treated with autologous cell sheet-based gene therapy showed ≥ 50% healing at 6 months, ...

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.

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 ...

The FDA has approved a ready-to-dilute, multi-dose formulation of thiotepa (Tepylute) for use in breast and ovarian adenocarcinomas, according to a news release on April 29 from Shorla Oncology, the ...

An IL-5 inhibitor drug, Fasenra competes with GlaxoSmithKline’s Nucala (mepolizumab), which has been approved in Japan since March 2016 and was first to market in the US and EU.