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.
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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.
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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.
Pfizer announced its RSV vaccine candidate PF-06482077 or RSVpreF, received Breakthrough Therapy designation from the U.S. Food and Drug Administration.