A linker drug from Byondis that boosts the targeting power of Roche’s Herceptin helped patients with a certain type of advanced breast cancer live longer without disease progression in a phase 3 clinical trial.
Though wearable devices have proven to be incredibly helpful in monitoring a variety of health conditions—from diabetes to atrial fibrillation—the FDA is sending Verily back to the drawing board in its efforts to add a Parkinson’s disease symptom assessment to its clinical research-focused smartwatch.
Bayer’s Parkinson’s disease stem cell therapy has officially landed in the clinic while another treatment for the neurodegenerative movement disorder is seeking patients.
Biogen’s shares may have been halted just ahead of its aducanumab approval, but Eli Lilly’s shares reaped the benefits.
The FDA has lifted a clinical hold placed on bluebird bio’s sickle cell gene therapy in February, making way for the company to get a phase 1/2 trial and phase 3 study of the treatment back on track.
FDA’s ‘intellectually insulting’ aducanumab decision opens up a regulatory foothold for leading competitors
The FDA seems to have set a new regulatory standard with its accelerated approval of Biogen’s aducanumab in Alzheimer’s disease. So now what?
Grail launches long-awaited Galleri blood test, its groundbreaking multi-cancer screening diagnostic
Grail took a major step forward in its quest to deliver a single blood test capable of detecting the presence of multiple cancers with the long-awaited launch of its Galleri diagnostic.
You’d think Amgen would still be celebrating in the halls after scoring an FDA approval for the KRAS inhibitor Lumakras just one week ago, but there’s just too much to do.
Novartis rolls out encouraging phase 2 data in rare kidney diseases with little competition in sight
Novartis rolled out results from two phase 2 clinical trials for investigational kidney disease medicine iptacopan that showed stabilization of kidney function in one and the reduction of a key marker for kidney disease progression in the other.
To follow up on what it’s described as its “best year ever,” Dexcom has accelerated the development of the newest version of its mainstay continuous glucose monitor in 2021—and delivered new clinical data showing CGM systems can provide significant benefits to patients with Type 2 diabetes, which the company has pegged as a major growth market.