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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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The rare disease drugmaker is facing potential competitors for achondroplasia drug Voxzogo. Is a big M&A deal with two approved assets enough to maintain investor interest?
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
A rapturous response to data published last year for Pelage’s hair loss candidate overwhelmed the biotech. Now, the company is ready to show the world the science behind the breakthrough.
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Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
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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.
This is the third episode of Denatured’s discussion on diversity, equity and inclusion. Here, our guests discuss imperatives around access and accountability.
Agenus is now looking for alternative pathways to initiate a Phase III trial for BOT/BAL, including potential partnerships.
Fresh off its $13-billion acquisition of medical devices developer Shockwave Medical, Johnson & Johnson is expecting greater business growth in the future.
As the DOJ and SEC look into two of its senior employees, Cassava Sciences’ CEO and one senior vice president have departed the company.
The last few months have been difficult for Gilead, with several late-stage failures and development discontinuations. Amid these problems, Merdad Parsey will be stepping down from his CMO role early next year.
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