FDA
On the heels of J&J’s Talvey, Pfizer’s bispecific antibody Elrexfio has secured an accelerated approval as another off-the-shelf treatment option for patients with relapsed or refractory multiple myeloma.
FEATURED STORIES
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
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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.
After Karyopharm submitted Phase III data from its SIENDO study on Selinexor, the FDA said that it is unlikely to support an sNDA approval for the drug.
The FDA asked Finch to pause enrollment for the trial on CP101 in recurrent C. difficile infection, pending details on how SARS-CoV-2 donor samples will be shipped to the vendor.
Belgium-based Celyad Oncology voluntarily paused a clinical trial with Merck after two deaths. Getting CAR T therapies to work in solid tumors has proven to be a difficult challenge.