The US regulatory agency has decided the long-acting opioid's benefits no long outweigh its risks, sparking concern that other strong steps on opioid abuse could be coming.
The US FDA’s request that Endo Pharmaceuticals Inc. remove Opana ER (oxymorphone extended-release) from the market due to safety issues could leave other opioid product marketers unsettled that they too could face the same fate.
On June 8, FDA announced it has asked Endo to remove the long-acting opioid because the drug’s reformulation in 2012 resulted in a shift in the
Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.
The company drew praise from the Trump administration as one of multiple companies announcing multibillion-dollar investments in US manufacturing and R&D.
The novel RAF/MEK inhibitor and FAK inhibitor are the first treatment approved specifically for KRAS-mutated recurrent low-grade serious ovarian cancer (LGSOC).
HTX-001 targeting the long non-coding RNA known as Wisper is being developed for non-obstructive hypertrophic cardiomyopathy. HAYA partnered with Lilly last year in obesity.
HTX-001 targeting the long non-coding RNA known as Wisper is being developed for non-obstructive hypertrophic cardiomyopathy. HAYA partnered with Lilly last year in obesity.
Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’
Mid-sized Japanese pharma firm to acquire tobacco giant’s pharma operations and take private the listed Torii Pharmaceutical business, in bid to build sales reach and strengthen manufacturing.
