Lilly cancer drug lands accelerated FDA approval
Lartruvo is the first front-line therapy approved by the FDA to treat soft tissue sarcomas since doxorubicin more than 40 years ago.
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Lilly drug for Alzheimer’s gets fast-tracked by FDA
Named AZD3293, the drug belongs to a novel class of drugs that block production of amyloid, a protein that causes plaque to build up in the brain of Alzheimer’s patients.
Lilly stock rises after FDA panel backs new Jardiance label
A hot-selling drug for diabetes sold by Eli Lilly and Co. and a co-partner just got another potential boost, as a government panel narrowly recommended that the companies should be allowed to claim that the drug cuts the risk of cardiovascular death.
Lilly angles for arthritis blockbuster
Within six months, Eli Lilly and Co. could know whether the Food and Drug Administration has approved its latest drug, baricitinib, a once-a-day tablet for treating rheumatoid arthritis.
Lilly wins FDA approval for plaque psoriasis drug
For Eli Lilly and Co., the approval rewards a decade-long effort to re-enter the biotech and autoimmune spaces that it helped pioneer in the 1980s but then abandoned in the 1990s.
FDA OKs once-a-day insulin that could be blockbuster for Lilly
The FDA said Wednesday it approved Basaglar based on data showing it is safe and effective and works similarly to Lantus, the world’s top-selling insulin.
FDA approves female sex pill, but with safety restrictions
The Food and Drug Administration on Tuesday approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
Lilly, partner sue Lupin over generic testosterone
Indianapolis-based Eli Lilly and Co. and Acrux DDS Pty Ltd. have filed a lawsuit against Lupin Pharmaceuticals Inc. for alleged infringement of patents that cover the testosterone treatment Axiron.
Warnings ordered on testosterone drugs like Lilly’s Axiron
Makers of testosterone drugs must change the products’ labels to clarify that they are approved for only certain disorders, not to help men deal with aging, U.S. regulators said.
Lilly to delay U.S., EU approval of basal insulin
Although the experimental diabetes drug is in final-stage testing and showing promising results, Lilly wants to better understand its effect on liver fat.
FDA approves Eli Lilly’s injectable diabetes drug
The agency on Thursday cleared the drug, Trulicity, as a weekly injection to improve blood sugar control in patients with type 2 diabetes, which affects more than 26 million Americans.
Testosterone drugs need study on heart risks, FDA panel says
Drugmakers, including Eli Lilly and Co., should conduct new trials to assess the heart risks of testosterone therapies used by millions of men last year, advisers to U.S. regulators said.
Recent wins worth $4B to Lilly market value
Lilly is finally putting meat on the bones of its predictions about its experimental diabetes and cancer drugs. That gives investors the certainty they crave that Lilly’s future revenue won’t remain in its 2014 doldrums.
Lilly says new insulin fares better than rival’s in late-stage tests
The Indianapolis-based drugmaker said Thursday that peglispro produced statistically significant lower blood sugar levels in patients when compared to people who took the Sanofi insulin Lantus in two late-stage studies of people with type 1 diabetes.
Lilly wins tentative approval for diabetes drug
Final approval could be delayed until mid-2016 due to a claim of patent infringement by drugmaker Sanofi.
Indy startup has rare disease in its sights
Founders of Chondrial Therapeutics believe that if further testing validates their treatment for Friedreich’s ataxia, it could be a blockbuster with annual sales topping $1 billion.
FDA approves Lilly, Boehringer diabetes drug
The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes who also are trying to control their condition with diet and exercise.
Lilly wins approval for potential blockbuster drug
The Indianapolis-based pharmaceutical maker gets a much-needed boost with FDA approval for gastric-cancer drug ramucirumab, which quickly could account for $1 billion in annual sales.
Pfizer, Lilly drugs slow advanced breast cancer in studies
Pfizer Inc., Eli Lilly and Co. and Novartis AG have dug an idea out of the pharmaceutical dustbin to create new medicines that are showing blockbuster potential.
Would-be Lilly foe wins U.S. panel backing for inhaled insulin
Advisers to the Food and Drug Administration voted 13-1 and 14-0 that the drug, Afrezza, should be approved for Type 1 and Type 2 diabetes, respectively. The FDA doesn’t have to follow the panel’s recommendation.