Phase 1
As 2022 comes to its conclusion, the FDA has a handful of Prescription Drug User Fee Amendments still to wrap up. Here’s a look at that and more.
At ASH 2022, established hematology leaders like AstraZeneca, Janssen and Merck will showcase new data, and new players like Vega Therapeutics will launch new programs.
AVROBIO is planning a Phase II/III registrational trial for its Gaucher Disease Type 3 (GD3) gene therapy candidate, AVR-RD-02, in 2023.
Editas Medicine released positive proof of concept data Tuesday morning from the first patients dosed with its experimental CRISPR-based gene therapy for sickle cell disease.
Mirati’s adagrasib demonstrated a solid safety profile in new data released Monday. Despite this, the company’s stock fell 8% in after-hours trading.
Monday, Verve Therapeutics revealed that the FDA has officially requested several buckets of additional safety information to lift the hold on its lead candidate, VERVE-101.
The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday.
SQZ Biotechnologies is slashing 60% of its workforce and looking for a new CEO after initiating a strategic prioritization to focus on its cell therapy platform for solid tumors.
Nectin Therapeutics announced dosing of the first solid tumor patient in a Phase I clinical trial while additional investors jumped in to expand the company’s Series A to just over $25 million.
With a $1.36 billion buyout, Merck bolstered its oncology program with the acquisition of Biotech Bay-based Imago Biosciences, a company focused on chronic bone marrow cancers.
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