FDA
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
FEATURED STORIES
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
When the variance can’t be modeled, even disciplined biotech investors stop deploying. Here’s the cheapest fix for biotech’s investability problem.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The U.S. Food and Drug Administration (FDA) has approved BioXcel Therapeutics’ Igalmi, a drug designed to reduce agitation episodes in bipolar disorder and schizophrenia patients.
The Accelerated Approval Integrity Act of 2022 (H.R. 6963) aims to remove loopholes in the FDA’s accelerated approval pathway. The bill, however, fails to adequately consider the whole picture.
Kite Pharma, a subsidiary of Gilead, announced that its Yescarta® has been approved by the U.S. Food and Drug Administration (FDA).
The U.S. FDA placed a partial hold on CytoDyn’s HIV program and a full clinical hold on its COVID-19 program in the U.S.
Orchard Therapeutics announced today that it intends to focus its hematopoietic stem cell (HSC) gene therapy platform exclusively on severe neurometabolic diseases and early research programs.
Biogen will await word after submitting the final study protocol for its confirmatory Phase IV ENVISION trial of Aduhelm to the U.S. Food and Drug Administration (FDA).
Despite being represented in clinical research, no solutions have been found to circumvent the effects of Alopecia areata. However, there may be hope.
Without holding a meeting of its vaccines advisory committee, the U.S. Food and Drug Administration (FDA) authorized a fourth booster shot for everyone 50 years of age and older.
Antares Pharma has announced that the U.S. Food and Drug Administration has granted approval to its therapeutic Tlando intended for testosterone replacement therapy (TRT).
The FDA released materials for review ahead of Wednesday’s meeting and it appears to paint a picture of insufficient data for approval, noting it is “not exceptionally persuasive.”