Lilly’s push into pain research starting to pay off
In recent months, the drugmaker has won federal approval to sell a drug called Emgality for two conditions: migraine pain and cluster headaches.
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Trump orders simpler path for genetically engineered food
The move comes as companies are turning to newer genetic engineering techniques that make it easier to tinker with the traits of plants and animals.
Food regulators pushing for clarity on expiration dates
By clarifying terms such as “Sell by” and “Use by,” U.S. regulators are trying to prevent people from prematurely tossing products and to reduce the mountains of food that goes to waste each year.
Ex-employees to testify exec knew drugs were dangerous
Paul Elmer, who founded Pharmakon 16 years ago and shut it down three years ago, faces charges of adulterating compounded drugs, conspiracy and obstructing a U.S. FDA investigation.
FDA chief Gottlieb steps down after nearly two years
Scott Gottlieb bucked expectations by pushing the agency to expand its authorities in several key ways, including an unprecedented effort to make cigarettes less addictive by requiring lower nicotine levels .
Senators ask FDA to update rules on CBD, hemp products
Congress legalized the production and sale of industrial hemp and hemp derivatives, including CBD. But FDA Commissioner Scott Gottlieb has restated his agency’s stance that CBD is a drug ingredient and therefore illegal to add to food or health products without his agency’s approval.
Americans, Canadians warned not to eat romaine lettuce
FDA Commissioner Scott Gottlieb said the FDA wanted to issue a warning about a new E. coli outbreak before people gathered for Thanksgiving meals, where the potential for exposure could increase.
FDA to crack down on menthol cigarettes, flavored vapes
The move represents a major step to further push down U.S. smoking rates, which have been falling for decades.
E-cigarettes facing new sales restrictions from FDA
New limitations will be placed on e-cigarettes, according to a senior FDA official, restricting sales of many popular fruit flavors amid what the health agency has called an epidemic of youth use.
Opioid alternative from Lilly, Pfizer shows promise in study
The experimental drug eased arthritis pain in hard-to-treat patients without major safety concerns, a key step in creating a new class of medications that may one day offer an alternative to narcotics.
Migraine drug from Eli Lilly approved by FDA
Eli Lilly and Co. received clearance Thursday from U.S. regulators for a new migraine drug that will be the third in a promising class of therapies for patients who suffer from the recurrent, painful headaches.
Competitor beats Lilly to market with migraine drug approval
The competition for the multi-billion dollar migraine market is set to heat up with the FDA expected to decide on Lilly’s migraine therapy next month.
In setback for Lilly, FDA limits dosage, slaps warning on new arthritis drug
The Indianapolis-based drugmaker has been working for years to develop the much-anticipated drug, which some analysts had said might ring up $2 billion a year in sales.
Gene therapies that could transform diseases get easier FDA path
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.
Congress gives dying patients easier access to unproven drugs
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.
Indiana-based Rose Acre Farms recalls 200M eggs over salmonella concerns
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.
Lilly signs licensing deal with biotech startup for diabetes drug
Under the agreement, Lilly will pay Sigilon Therapeutics up to $410 million if the technology hits certain milestones.
FDA opens new path for Alzheimer’s therapy as failures mount
The Food and Drug Administration proposal will create new opportunities for drugmakers after repeated failures from companies including Indianapolis-based Eli Lilly and Co.
FDA aims to expand early-approval program for promising drugs
The Food and Drug Administration wants to help patients get faster access to promising cancer treatments, FDA Commissioner Scott Gottlieb told House lawmakers Thursday.
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.