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Modernaâs mRNA-1010 was expected to contribute $1 billion to the companyâs coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.
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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 biotechâs shares tumbling.
A rapturous response to data published last year for Pelageâs 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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The Swiss pharma is paying $150 million upfront to gain rights to Monte Rosaâs VAV1-targeting molecular glue degraders, led by a Phase I candidate which holds therapeutic promise for immune-mediated diseases.
Jefferies analyst Kelly Shi in a Sunday note to investors said that both data drops for Revolution Medicinesâ experimental RAS inhibitors are positive and could be âsynergisticâ in the first-line setting for pancreatic ductal adenocarcinoma.
Orlynvah is the first oral penem approved in the U.S. and Iterum Therapeuticsâ first FDA-approved product. CEO Corey Fishman said the company will renew its efforts to look for a potential partner to maximize value for its stakeholders.
William Blair analyst Myles Minter in a Monday note to investors said that Vertexâs povetacicept âhas maintained its potential to be a best-in-class assetâ in the IgA nephropathy space and could become a âmultibillion-dollar pipeline-in-a-drug productâ for autoimmune disorders, while âoutstanding questionsâ remain for Biogenâs felzartamab before moving into pivotal studies.
As therapies for rare and neurological diseases earn accelerated approval, experts laud the programâs intent while remaining concerned about confirmatory trials and clinical efficacy, especially as products greenlit under this pathway are pulled from the market.
With Sareptaâs gene therapy Elevidys now available to a majority of Duchenne muscular dystrophy patients, experts express cautious optimism while emphasizing the need for further data.
Vertex may have pivoted away from the space, but candidates in development by Arrowhead/Takeda, Wave, Korro and others could address the damage underlying alpha-1 antitrypsin deficiency and make todayâs treatments a thing of the past.
Pfizer CEO Albert Bourla is in a tough spot as activist investor Starboard Value continues to call for a change in the companyâs leadership. However, analysts are supportive of the embattled executive.
The French drugmakerâs newly launched respiratory syncytial virus antibody Beyfortus far exceeded analyst expectations, bringing in almost $700 million in the third quarter. Leerink Partners analyst David Risinger in a Friday note to investors said Sanofi expects Q4 Beyfortus sales similar to Q3.
The CDCâs vaccine advisors on Thursday maintained that respiratory syncytial virus immunization is only recommended for adults aged 75 and older, and in seniors 60 to 74 years who are at risk of severe disease.