Companies have claimed improvements to yield, batch consistency and output while acknowledging the risks and challenges ...

Earlier this month, the FDA backed off on a pause in shipments of the chikungunya vaccine Ixchiq to older adults. Now, the ...

Arnatar is developing ART4, an antisense oligonucleotide that ups the expression of its target protein to treat a rare ...

Thousands of employees across the Department of Health and Human Services are set to lose their collective bargaining rights ...

The FDA Adverse Event Reporting System, which Commissioner Marty Makary called “clunky,” previously published updates on a ...

The biotech sector has not seen an IPO in six months. The market has remained frozen amid broader macro pressures and the ...

The mad rush for safe and effective obesity drugs has winners—including Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy—and ...

The platform strategy of using one molecule to target an underlying biological pathway to address many different diseases can ...

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

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

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

Drugs are being invented and manufactured right here in the U.S. by Americans, for Americans. So why doesn’t the industry ...