New therapies that could cure diseases caused by defective genes will get quicker approval from U.S. regulators, part of an effort by the Food and Drug Administration to keep pace with one of biotechnology’s fastest-growing fields.
President Donald Trump’s interest in the bill stems from a push by Vice President Mike Pence, who championed the initiative when he was governor of Indiana.
A notice posted on the Food & Drug Administration website says the eggs shipped to restaurants and grocery stores in nine states may be tainted with salmonella.
Under the agreement, Lilly will pay Sigilon Therapeutics up to $410 million if the technology hits certain milestones.
The Food and Drug Administration proposal will create new opportunities for drugmakers after repeated failures from companies including Indianapolis-based Eli Lilly and Co.
The Food and Drug Administration wants to help patients get faster access to promising cancer treatments, FDA Commissioner Scott Gottlieb told House lawmakers Thursday.
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.
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.
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.
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.
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.
The Indianapolis drugmaker said it will not be required to conduct another expensive, time-consuming clinical trial for the potential blockbuster.
Drug and medical device makers would pay higher user fees under legislation the U.S. Senate approved and sent to the president on Thursday.
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.
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 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.
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.
The drug, which has the proposed brand name Olumiant and is approved for use in Europe, was expected to be a big seller.
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.
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.
