Dawnzera is the first and so far only RNA-targeting therapy approved as a prophylactic treatment for hereditary angioedema ...

Vanda claims that two generics to its sleep disorder drug Hetlioz were approved despite inadequate data and is requesting ...

Krystal Biotech's decision follows the FDA’s rejection last month of Replimune’s RP1, which works similarly to Krystal ...

The FDA has identified critical lapses at a production facility operated by Novo Nordisk that is used by several drugmakers, ...

Washington has had notable life sciences job growth over the past 10 years, according to a Life Science Washington report.

In an open letter, Health and Human Services employees asked the Secretary to stop and disavow the spread of health ...

The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants.

In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses clinical trial fail rates and AI’s potential to reduce preclinical costs with Mutlu Dogruel, VP of AI and Mark ...

Looking for a biopharma job in Massachusetts? Check out the BioSpace list of nine companies hiring life sciences ...

Stealth BioTherapeutics originally submitted elamipretide for approval in January 2024, only to receive a rejection in May of this year. In addition to accepting the biotech’s resubmission, the FDA ...

President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.

The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...