FDA’s tighter scrutiny on drug class leads TG Therapeutics to pull out of cancer
TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places […]
TG Therapeutics is pausing its cancer drug research and withdrawing the approved cancer drug Ukoniq from the market. The move comes as the FDA places […]
Seelos’ SLS-005 (Trehalose) Receives EC’s Orphan Drug Designation to Treat Amyotrophic Lateral Sclerosis Published: May 28, 2021 | Tags: Seelos, SLS-005, Trehalose, EC, Orphan Drug […]
Shots: The BLA submission is based on P-III UNITY-CLL trial evaluating ublituximab + Ukoniq (U2) vs obinutuzumab + chlorambucil in a ratio (1:1) in 420 […]
BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, […]
Shots: The company has initiated patient enrolment in P-III ULTRA-V trial evaluating Ukoniq + ublituximab + venetoclax, vs Ukoniq + ublituximab (U2) in patients with […]
TG Therapeutics has completed its rolling FDA filing for its U2 combination therapy consisting of the antibody ublituximab with the oral drug Ukoniq (umbralisib) as […]
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. […]
The US FDA has approved 7 NDAs and 1 BLA in Feb 2021, leading to treatments for patients and advances in the health care industry. […]
Bristol-Myers Squibb finally has FDA approval for its CAR-T therapy liso-cel, which has been cleared by the US regulator as Breyanzi for certain forms of […]
TG Therapeutics provided one of the highlights of the American Society of Hematology (ASH) conference earlier this month after lifting the lid on phase 3 […]
US biotech TG Therapeutics has begun a rolling filing with the FDA for its combination therapy for chronic lymphocytic leukaemia, in a challenge to Roche. […]
The FDA has accepted TG Therapeutics’ filing for its lymphoma drug umbralisib, which if approved could compete against a combination therapy from Bristol-Myers Squibb and […]
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