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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David S. Knopman and Joel S. Perlmutter both resigned from the committee after the approval of the drug aducanumab.
Pfizer says it expects the U.S. CDC’s ACI to meet in October to recommend the appropriate and safe use of pneumococcal vaccines, including PREVNAR 20, in adults.
Bharat will conduct Phase IV studies to check real-world efficacy against the virus, while Ocugen says Covaxin will be a valuable tool in helping to end the COVID-19 pandemic.
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
Results from the Phase III TULIP® study show an antibody-drug conjugate from Byondis significantly prolonged PFS in patients with pretreated HER2-positive metastatic breast cancer.
The tool developed by On Target boosts the ability of surgeons to find and remove cancerous lesions during surgical procedures, increasing progression free and overall survival.
Novartis flexed its clinical muscles over the weekend, announcing results from multiple studies including different types of cancer and kidney disease.
The U.S. Food and Drug Administration granted approval of Biogen’s aducanumab for the treatment of Alzheimer’s disease.
The FDA lifted the clinical holds on bluebird bio’s sickle gene therapy and its betibeglogene autotemcel gene therapy for adults, adolescents and children with TDT.
United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.