Food and Drug Administration (FDA)
NEWS
Compass and AstraZeneca have both provided updates to their clinical therapeutic programs focused on biliary tract cancers.
Despite the loss of its COVID-19 antibody, REGEN-COV, earlier this year, Regeneron posted a positive first quarter driven primarily by sales of Dupixent and Eylea.
The FDA accepted Bayer’s supplemental New Drug Application for its proposed oral treatment for metastatic hormone-sensitive prostate cancer.
Three long-time FDA officials, Dr. Peter Marks, Dr. Janet Woodcock and Dr. Robert Califf wrote an op-ed in JAMA describing the reality that COVID-19 represents “the new normal.”
GPH101 is an investigational next-generation gene-edited autologous hematopoietic stem cell (HSC) therapy.
Spero is reducing a huge chunk of its staff to minimize expenses and reallocate resources toward more promising projects in anticipation of the FDA’s decision on its NDA for tebipenem HBr.
Denali Therapeutics, Inc. has announced that dosing has begun for participants of a Phase II clinical trial that intends to evaluate the potential of SAR443820 (DNL788) in patients with amyotrophic lateral sclerosis (ALS).
Biogen announced the leadership change in its quarterly financial report. Michel Vounatsos plans to depart the company when a new CEO is found.
Humacyte’s engineered blood vessels, human acellular vessels, are in a position to take tissue regeneration from a laboratory possibility to a commercial reality.
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