FDA
The newly approved HIV drug Idvynso will also help Merck diversify as loss of exclusivity looms over its top-selling product, the mega-blockbuster cancer drug Keytruda.
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The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
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United claims Liquidia and a former employee misappropriated its trade secrets such as regulatory submissions and detailed financial forecasts for its inhaled treprostinil.
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.
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.
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.
The newly approved drug, Lybalvi, is a once-daily oral antipsychotic drug that is both a maintenance monotherapy or for the acute treatment of manic or mixed episodes.
Amgen reunites with Kyowa Kirin on the development and potential commercialization of KHK4083, an atopic dermatitis drug, which impacts nearly 30 million people worldwide.