Lilly’s middling lung cancer drug wins FDA approval with a restrictive label

Damian Garde Eli Lilly won FDA approval for a lung cancer treatment that posted only a marginal survival benefit in late-stage clinical trials, gaining clearance to treat a small population ...

GlaxoSmithKline bags an FDA OK for its asthma drug with eyes on a respiratory turnaround

Damian Garde GlaxoSmithKline won FDA approval for an antibody designed to treat severe asthma, leading a pack of drugmakers at work on similar therapies as it seeks to bolster its respiratory ...

Isis and GlaxoSmithKline eye Phase III with a rare disease drug

Damian Garde GlaxoSmithKline and partner Isis Pharmaceuticals are plotting a pivotal trial in the rare TTR amyloid cardiomyopathy, an inherited disease that impairs the heart muscle. FierceBiotech ...

Daiichi Sankyo’s cancer drug wins the FDA’s coveted ‘breakthrough’ tag

Damian Garde Daiichi Sankyo picked up the FDA's breakthrough therapy designation for a Phase III cancer drug, putting it in line for preferential access to agency experts as it ...

AstraZeneca’s gout drug wins faint praise from FDA advisers

Damian Garde A majority of independent FDA advisers recommended approval for AstraZeneca's new gout drug, but not without noting that the treatment's safety profile presents ...

The FDA is lukewarm on those hyper-valuable vouchers for fast drug reviews

Damian Garde Big Pharma has been willing to pay hundreds of millions of dollars for a shortcut to FDA approval, buying up priority review vouchers created to incentivize new drugs for ...

FDA puts off its decision on Newron’s Parkinson’s drug

Damian Garde Italian biotech Newron Pharmaceuticals will have to wait another three months for a final FDA decision on its investigational Parkinson's treatment. FierceBiotech News

COMMENTARY: Why would Martin Shkreli hike an old drug price by 5000%? Only a ‘moron’ would ask

John Carroll FierceBiotech News

Geron jumps as its J&J-partnered cancer drug shows promise in Phase II

Damian Garde Long-troubled drug developer Geron is touting what it calls "unprecedented" early results for its lead cancer drug, sending the biotech's share price up as ...

After partnering with Big Pharmas, Incyte bags its own PD-1 drug in $795M deal

John Carroll After signing up for combo studies with all the leaders in the checkpoint inhibitor race, Incyte has found a checkpoint program for itself. FierceBiotech News

Alnylam, Medicines Co. say next-gen PCSK9 drug has blockbuster potential

John Carroll FierceBiotech News

Judge halts lawsuit blaming Purdue, Endo and others for epidemic of drug abuse

Eric Palmer It was attention-grabbing when California sued a handful of drugmakers, accusing them of lying about the safety of their high-powered painkillers and blaming them for an ...
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