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Despite hotly debated biomarkers and failed or delayed confirmatory trials, the accelerated approval program has a track record of propelling R&D for some of medicine’s most challenging illnesses.
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After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.
A complex state vs. federal regulatory scheme allows drug compounders to advertise drugs without disclosing risks like a pharma company must do. Experts say it’s time for the FDA to crack down.
From a small team of researchers and skipped salaries, CEO Michelle Xia has steered Akeso to become one of the most exciting companies in the industry today.
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Pfizer Inc. announced that the U.S. Food and Drug Administration’s Antimicrobial Drugs Advisory Committee voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.
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Read our takes on the biggest stories happening in the industry.
The FDA has vowed to fix a pharma ad loophole—but they’re targeting the wrong one.
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After a long and challenging journey for its stem cell therapy NurOwn, BrainStorm Cell Therapeutics has aligned with the FDA on the parameters of a Phase IIIb ALS trial that is expected to begin by the end of 2024.
With GLP-1 receptor agonists expected to dominate the weight loss market in the near term, several young companies are building on this mechanism, while others are taking a completely different approach.
While type 2 diabetes and obesity are the primary conditions currently treated with blockbuster GLP-1 drugs, Novo Nordisk and Eli Lilly aim to enter additional markets.
BioSpace has updated our Job Search Toolkit, including recent resources to help you succeed with your next job search.
Cell therapy biotech Artiva Biotherapeutics plans to use the funds raised to support the development of its AlloNK therapy for systemic lupus erythematosus.
GRO Biosciences will use the Series B funds to launch a Phase I trial for ProGly-Uricase, its investigational therapy for gout.
In a bid to take advantage of Humira’s slow loss of market share, Boehringer Ingelheim is offering its biosimilar at a 92% discount exclusively to patients who buy the product on GoodRx.
While its investigational regimen fell short of the primary efficacy endpoint, AVEO dug into data from its control group and touted a “clinically meaningful” improvement in progression-free survival in patients receiving Fotivda monotherapy.
Already approved for erosive gastroesophageal reflux disease, Phathom’s Voquenza is now authorized to treat patients with non-erosive GERD.
Novartis’ second-quarter earnings, announced Thursday, show strong performance of its blockbuster drugs, prompting the company to raise its year-end guidance.