FDA
Amid a supply shortage of the attention-deficit/hyperactivity disorder and binge-eating disorder medication, the regulator has cleared a slew of generic drugs of Takeda’s Vyvanse pill.
FEATURED STORIES
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.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
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It was a busy week for clinical trial announcements. Here’s a look.
Lamassu Bio, Inc. is setting its sights on the unmet needs of the pharmaceutical industry as it announces a new venture to develop therapeutics for cancer.
Eiger BioPharmaceuticals announced that its COVID-19 therapeutic, Peginterferon Lambda reduced the risk of hospitalization and emergency room visits by 50%.
Tetra Bio-Pharma announced that its investigational new drug involving cannabinoids, QIXLEEF, received guidance to strengthen its nonclinical and toxicological data from the FDA.
There is some evidence that COVID-19 infection might be linked to an increase in diabetes, particularly Type 1 diabetes, which is an autoimmune disease most commonly diagnosed in children.
The U.S. Court of Appeals for the Federal Circuit denied Biogen a second look into the patent dispute filed against Mylan for Biogen’s Multiple Sclerosis (MS) drug, Tecfidera.
BrainStorm Cell Therapeutics’ NurOwn has taken the amyotrophic lateral sclerosis (ALS) community by storm with new genetic data from its Phase III trial.
Several biopharma companies celebrate the U.S. Food and Drug Administration’s approval for clinical trials involving therapeutics for cancer treatment.
Healthcare giant Sanofi and cancer-focused biotech company Seagen Inc. announced an exclusive collaboration agreement to develop antibody-drug conjugates (ADCs) for cancer treatments.
Biogen reported new data from a long-term extension phase of the Phase III clinical studies of Aduhelm (aducanumab) for Alzheimer’s disease.