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.
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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.
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Harpoon Therapeutics, Inc. has unfortunately announced that it will move to discontinue one of its promising T cell engager biologics, HPN424.
Releuko is expected to launch in the third quarter of 2022 as a treatment for neutropenia, a low white blood cell condition experienced by chemotherapy patients.
Recent technological advancements have pushed pharma employees to embrace new technologies and innovations in different areas.
BioNTech announced an expansion on its collaboration with Regeneron to continue advancing mRNA technology and develop novel treatments for a variety of cancers.
Currently, women with breast and ovarian cancers have limited treatment options. Anixa Biosciences, ImmunoGen and IMV are working to change that.
The FDA clinical hold comes after Alpine reported a patient died during the NEON-2 trial.
BMS and Opdivo’s blockbuster checkpoint inhibitor picked up a new regulatory win after the FDA approved the cancer drug in combination with platinum-doublet chemotherapy.
China has become a leader in biotech in the last five years, especially in CAR-T therapies. Companies like Johnson & Johnson are on the prowl to acquire Chinese companies to form collaborations.
As COVID-19 cases fall in the wake of the latest surge from the Omicron variant, the question on the minds of many is, what comes next for these Pfizer and Moderna?
The FDA turned down Ocugen’s Emergency Use Authorization request for Covaxin in children 2 to 18, which the company is co-developing with India’s Bharat Biotech.