Phase 2
The U.S. FDA granted Fast Track Designation to three biopharma companies for the treatment of LGMD, episodic bleeding and leukemia.
Adamis has sent a letter to stockholders urging them to re-elect all the five board members as part of a strategic move to continue and maintain its current growth initiatives.
The U.S. Food and Drug Administration (FDA) has made the decision to grant Breakthrough Therapy Designation to Mirati Therapeutics’ adagrasib for the potential treatment of non-small cell lung cancer (NSCLC) in patients harboring the KRASG12C mutation after systemic therapy.
It was a busy week for clinical trial news. Here’s a look.
Multiple pharma company stocks make their first appearance on the Nasdaq this morning to advance the next-generation therapeutics. BioSpace takes a look at some of these IPOs.
The Oncologic Drugs Advisory Committee (ODAC), as part of the U.S. Food and Drug Administration (FDA), has voted 13-to-4 against supporting the accelerated approval of Incyte’s PD-1 inhibitor for squamous cell carcinoma.
The first interim analysis of a three-arm Phase II ARC-7 trial shows Arcus Biosciences’ anti-TIGIT immunotherapy combination features “encouraging clinical activity” as an initial therapy for patients with metastatic non-small cell lung cancer (NSCLC).
The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.
The U.S. FDA has had a mix of announcements this week, from drug approvals to the acceptance of NDAs and INDs. Here’s a look.
Fulcrum achieved what the company is calling a clinical first. Data showed that using losmapimod slowed the progression of FSHD and demonstrated improved function in patients.
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