Approvals

The U.S. Food and Drug Administration granted approval of Biogen’s aducanumab for the treatment of Alzheimer’s disease.
The FDA lifted the clinical holds on bluebird bio’s sickle gene therapy and its betibeglogene autotemcel gene therapy for adults, adolescents and children with TDT.
FDA
United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.
FDA
Wegovy is the first and only once-weekly GLP-1 receptor agonist that’s been approved for weight control in people living with obesity. This is the same drug used to treat type 2 diabetes.
FDA
It didn’t take too long before a lawsuit was filed over Bristol Myers Squibb’s failure to meet a deadline for a $9 Contingent Value Rights agreement tied to the company’s merger with Celgene.
REGEN-COV’s 1,200 mg dose is authorized to treat mild-to-moderate COVID-19 in adults and children 12 years and older who weigh 40 kilograms or more.
Alzheimer’s patients and their families wait with hope that this will mean some offer of treatment, while physicians that treat Alzheimer’s patients are mulling the implications of the drug, often with hesitancy and skepticism.
Shares of Protagonist Therapeutics climbed nearly 4% in premarket trading after the company announced its lead drug candidate rusfertide snagged Breakthrough Therapy Designation from the U.S. FDA.
FDA
The new vaccination, dubbed VAXELIS, is indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b.
The new approval for Cosentyx marks the first for a pediatric patient population in the U.S. Here’s everything you need to know about this new drug from Novartis.
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