Drugs

Halda Gets Fast Track for Prostate Cancer Drug

FDA has granted Halda Therapeutics a Fast Track designation for HLD-0915, which the company describes as a drug candidate for treating metastatic castration-resistant prostate cancer (mCRPC). In preclinical prostate cancer models, the therapy showed tumor shrinkage, prostate-specific antigen declines, and activity in drug-resistant disease, it says.

The company is currently enrolling participants in a Phase 1/2 first-in-human trial (NCT06800313) evaluating HLD-0915 as an oral monotherapy for mCRPC. The trial will assess safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity, starting with a dose-escalation phase followed by expansion cohorts to further study efficacy and safety, Halda says.

mCRPC is an advanced stage of the disease that no longer responds to hormone therapy and has limited treatment options, it says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome