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 ...

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

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 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 ...

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

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

While the 10-fold increase in dose over injectable Wegovy has raised questions about the launch, Novo Nordisk has assured ...

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

There’s still much more to come from the White House on tariffs, but the European Union has now reached a trade agreement ...