As Alnylam Pharmaceuticals approaches its highly anticipated March 23 FDA decision date for a potential expansion of Amvuttra ...

Moderna is revamping its digital team, eliminating 10% of roles under two digital departments, affecting about 50 employees, ...

In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...

After two contentious Senate committee hearings on President Donald Trump’s nominee for HHS secretary, the votes are in: ...

Spanish CDMO Laboratorios Farmacéuticos Rovi, known simply as Rovi, is part of a parade of biopharma contractors struggling ...

Pfizer hopes a unique life-extension benefit for its Talzenna can serve to further expand the drug’s already ...

Axplora, a German CDMO that specializes in API small molecule and ADC production, will upgrade its manufacturing facility in ...

Welcome to Fierce Pharma's regulatory tracker for the first half of 2025. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and ...

Telehealth company Hims & Hers stirred up controversy by debuting a 2025 Super Bowl ad touting the benefits of its ...

More than 13 years after its initial FDA approval, Pfizer’s blood cancer drug Adcetris has nabbed another regulatory green ...

Astellas has invested heavily in novel technologies that are not necessarily the most successful or popular in the industry.

Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...