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The firm submitted data from a registrational study showing the drug's activity in adult and adolescent patients with NTRK fusion-positive solid tumors.
CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.
Amid an 18 percent increase in cancer drug sales, J&J executives shared hopes that recent overall survival data for the drug combo will be practice changing.
In the trial, researchers are evaluating Scancell's DNA cancer vaccines SCIB1 and iSCIB1+ alongside immunotherapy.
After VERVE-102 showed the ability to lower LDL-C and PCSK9 in the Heart-2 trial, the firm said it will advance the therapy to a Phase II study later this year.
After an earlier trial showed patients with elevated levels of a cardiac stress marker benefited from its cell therapy, the firm shifted focus to this subset.
On the heels of its acquisition by Ocuphire Pharma, Opus is planning next steps for its Leber congenital amaurosis type 5 ...
ACMG, NSGC, and others in the genetics community are monitoring whether the widely used online clinical genetics database ...
NEW YORK – The US Food and Drug Administration on Thursday granted full approval to Bayer's TRK inhibitor Vitrakvi (larotrectinib) for treating adult and pediatric patients with previously treated ...
NEW YORK – Amylyx Pharmaceuticals announced this week that it has dosed the first amyotrophic lateral sclerosis (AML) patient with its investigational antisense oligonucleotide therapy (ASO), AMX0114, ...
NEW YORK – The UK's National Institute for Health and Care Excellence (NICE) on Friday recommended that the National Health Service make AstraZeneca's AKT pathway inhibitor Truqap (capivasertib) with ...
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