bullish
Telix Pharmaceuticals - TLX591-CDx NDA submitted
SUMMARY
On 24 September 2020 Telix announced it had submitted its NDA to the FDA for approval of TLX591-CDx, its positron emission tomography (PET) imaging agent targeting prostate-specific membrane antigen (PSMA). The agency has a statutory 12 months to complete its assessment (two to accept the application and 10 to review). TLX591-CDx would be the company’s first approved product and it is in preparations to be ready to launch the product in 2021, which includes establishing distribution and supply-chain relationships.
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- Telix Pharmaceuticals - TLX591-CDx NDA submitted28 Sep 2020
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