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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Esai, Biogen, Diadem and ProMis all presented their findings on biomarker research at this year’s International Conference on Alzheimer’s and Parkinson’s Diseases.
Takeda faces yet another setback by the U.S. Food and Drug Administration for its parathyroid hormone, natpara.
Merck’s Keytruda has become an approved treatment for yet another indication: unresectable or metastatic advanced endometrial carcinoma. Know more about it here.
Ztalmy is Marinus’ oral suspension medication for patients ages two years and older who experience seizures linked with cyclin-dependent kinase-like 5 deficiency disorder.
BMS achieved a monumental milestone when the U.S. Food and Drug Administration approved Opdualag (nivolumab and relatlimab-rmbw) for the treatment of melanoma.
It was a busy week for clinical trial announcements. Here’s a look.
Lamassu Bio, Inc. is setting its sights on the unmet needs of the pharmaceutical industry as it announces a new venture to develop therapeutics for cancer.
Eiger BioPharmaceuticals announced that its COVID-19 therapeutic, Peginterferon Lambda reduced the risk of hospitalization and emergency room visits by 50%.
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.
There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.