FDA
As the new executive VP and chief development officer of BrainStorm, Dagher is tasked with securing FDA approval of NurOwn for the treatment of ALS.
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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Biogen reported new data from a long-term extension phase of the Phase III clinical studies of Aduhelm (aducanumab) for Alzheimer’s disease.
Incyte Corporation reported that the FDA has pushed back the review of the company’s supplemental New Drug Application (sNDA) for Opzelura (ruxolitinib cream) for vitiligo.
A new study out of Duke University added weight to the determination that asthma in children did not increase infection risk, children slow to get COVID vaccine and more COVID-19 news.
The U.S. FDA has approved Lynparza for the adjuvant treatment of patients diagnosed with germline BRCA-mutated HER2-negative high-risk early breast cancer.
AstraZeneca’s Fasenra hit a roadblock after the FDA issued a Complete Response Letter for chronic rhinosinusitis with nasal polyps (CRSwNP).
The FDA has a full PDUFA calendar for the second half of March for New Drug Applications and Biologics License Applications. Here’s a look.
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.