Novartis gets FDA nod for Tafinlar plus Mekinist to treat BRAF mutation-positive solid tumours
The drug combination was indicated for metastatic solid tumours with BRAF V600E mutations in adults and children aged…
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23 Jun 22
The drug combination was indicated for metastatic solid tumours with BRAF V600E mutations in adults and children aged…
22 Jun 22
A modified panel of CAFC reversed the decision upholding the validity of the Gilenya dosing regimen patent granted…
21 Jun 22
The NMPA approval is based on the interim analysis of the Phase 3 ORIENT-15 clinical trial, in which…
16 Jun 22
The rolling review is initially based on chemistry, manufacturing, and controls (CMC) data, which the vaccine manufacturers shared…
15 Jun 22
The US antitrust watchdog has issued a letter to the company that said the FTC was investigating whether…
14 Jun 22
Albrioza, also known as AMX0035, is an oral fixed-dose combination therapy that works to reduce neuronal cell death…
14 Jun 22
The FDA approval is supported by Lilly’s BRAVE-AA1 and BRAVE-AA2 clinical trials, which evaluated the efficacy and safety…
13 Jun 22
The US regulator required a patient notification about suicidal behaviour, where it has previously approved an expanded its…
09 Jun 22
The EC approval is based on positive results from the Phase ½ GO29781 study, which assessed the safety,…
08 Jun 22
The FDA approval is based on data from a Phase 3 trial which evaluated the efficacy and safety…