FDA
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
FEATURED STORIES
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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 study drug is a once-daily, two-week therapy developed by Sage Therapeutics and Biogen for major depressive disorder (MDD) and postpartum depression (PPD).
The company noted it would continue to assess the STAR study’s complete data set before confirming its future plans for clinical development of timrepigene emparvovec.
Avenue Therpeutics is facing the heat of rejection from FDA once again for its IV non-opioid painkiller tramadol. Here are the reasons behind the rejections
The FDA accepted its pre-Investigational New Drug request for a cell therapy treatment that could be a key factor in controlling HIV.
The month of June continues to be busy for the U.S. Food and Drug Administration. There are three PDUFA dates on the calendar for this week. Here’s a look.
Beigene presented results from three pivotal trials at the 26th EHA2021 Virtual Congress for the effectiveness of their checkpoint inhibitor tislelizumab in relapsed or refractory lymphoma.
Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
Although the COVID-19 pandemic is waning in the U.S., there is still plenty of research and news about the disease. Here’s a look.
The new study findings may pave the way for Bristol Myers Squibb to receive additional approval for Breyanzi in a vulnerable patient population.
The Pennsylvania-based eye disease company had to change its application from an Emergency Use Authorization to a full BLA approval.