FDA approving drugs at accelerated pace
Thirty-four new drugs—treating everything from cancer to rare genetic diseases—have been approved so far this year. That’s on pace to nearly double last year’s approvals.
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FDA acts to encourage generic competition for complex drugs
The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines.
FDA approves Lilly drug for common advanced breast cancer
U.S. regulators have approved a new medicine for treating a common type of breast cancer after it has spread to other parts of the body.
FDA’s consumer protection warnings falling under Trump
From January to July, the agency sent 265 warning letters to companies, notifying them of what it alleged to be serious violations of federal rules. That’s the lowest tally for the first seven months of any year since 2008.
Lilly competitor reaches $46.5M settlement with U.S. over safety info
Danish drugmaker Novo Nordisk says it has reached a settlement over allegations that it hadn’t properly communicated safety information when marketing a medicine to treat type 2 diabetes.
Lilly shares rise on surprising news from FDA on arthritis drug
The Indianapolis drugmaker said it will not be required to conduct another expensive, time-consuming clinical trial for the potential blockbuster.
Congress passes bill to fund FDA drug, medical device reviews
Drug and medical device makers would pay higher user fees under legislation the U.S. Senate approved and sent to the president on Thursday.
Lilly, Pfizer get boost for non-opioid pain drug
The companies say the drug, now in late-stage clinical trials, could be more effective for pain treatment than opioids—a dangerous category of pain killers that includes hydrocodone, morphine and fentanyl—without the abuse potential of such medications.
Pharmakon owner, compliance director face criminal charges
The owner and the director of compliance for Noblesville-based Pharmakon Pharmaceuticals Inc. have been charged with multiple criminal counts related to the sale of over-potent compounded painkillers that sickened at least three infants.
Lilly migraine drug provides relief in late-stage trials
Lilly is in a race with several pharmaceutical firms to develop migraine treatments using an approach known as anti-CGRP and that could create a multibillion-dollar market.
Wall Street punishes Lilly for latest drug setback; analysts grasp for answers
News that federal regulators rejected Lilly’s drug for arthritis sent the stock tumbling more than 5 percent Monday, and sent surprised analysts searching for answers.
Lilly’s rheumatoid arthritis pill rejected by regulators
The drug, which has the proposed brand name Olumiant and is approved for use in Europe, was expected to be a big seller.
Lawmakers hear bill to establish ‘hemp oil registry’ for seizure patients
One of the bill’s author said it is designed to help parents who are “up against a wall,” and he stressed that it should not be confused as a first step to medical marijuana legalization in the state.
At Eli Lilly, tears, heartbreak and renewed determination
Eli Lilly and Co. employees knew the Alzheimer's treatment solanezumab was not a sure bet. But that didn’t make the pain any less acute after the company announced the drug had failed to demonstrate effectiveness during a 2,100-patient Phase 3 clinical trial.
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.
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.