US FDA Accepts Tabelecleucel BLA Resubmission for EBV-PTLD
The US FDA has accepted Pierre Fabre’s tabelecleucel BLA resubmission for EBV-positive PTLD, with a target decision date of March 31, 2027.
Tabrecta | 15/10/2026 | By News Bureau
Natco Pharma Submits ANDA for Generic Version of TABRECTA
Natco claims to be the first company to have filed a substantially complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclusivity at the time of the potential launch of the product under certain circumstances.
TABRECTA | 31/08/2024 | By Aishwarya | 966
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