Product approvals

FILE - In this Monday, March 2, 2020 file photo, Gilead Sciences CEO Daniel O'Day speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House in Washington. Gilead, the pharmaceutical giant that makes remdesivir, a promising coronavirus drug, has registered it as a rare disease treatment with U.S. regulators on Monday, March 23, 2020, a status that can potentially be worth millions in tax breaks and competition-free sales. (AP Photo/Andrew Harnik)
March 24, 2020 - 9:11 pm
WASHINGTON (AP) — The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with U.S. regulators, a status that can potentially be worth millions in tax breaks and competition-free sales. What that specialty status will actually mean for the...
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This undated photo provided by Esperion Inc. shows the cholesterol-lowering drug Nexletol made by Esperion Therapeutics Inc. The Food and Drug Administration on Friday, Feb. 21, 2020 approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-high cholesterol and others who have heart disease and need to further lower their bad cholesterol.(Esperion Inc. via AP)
February 21, 2020 - 4:15 pm
TRENTON, N.J. (AP) — U.S. regulatorson Friday approveda new type of cholesterol-lowering drug aimed at millions of people who can't tolerate — or don't get enough help from — widely used statin pills like Lipitor and Crestor. The Food and Drug Administration approved Esperion Therapeutics Inc.’s...
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In this Nov. 5, 2019 photo, in St. Francis, Wis., Amy Carter looks at her Yorkshire terrier-Chihuahua mix Bentley, who has epilepsy. Carter, gives him CBD, which she says has reduced his seizures. The federal government has yet to establish standards for CBD that will help pet owners know whether it works and how much to give. But the lack of regulation has not stopped some from buying it, fueling a $400 million CBD market for pets that grew more than tenfold since last year and is expected to reach $1.7 billion by 2023, according to the cannabis research firm Brightfield Group. (AP Photo/Carrie Antlfinger)
Associated Press
January 07, 2020 - 11:43 am
Companies have unleashed hundreds of CBD pet health products accompanied by glowing customer testimonials claiming the cannabis derivative produced calmer, quieter and pain-free dogs and cats. But some of these products are all bark and no bite. “You'd be astounded by the analysis we've seen of...
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This undated photo provided by Amarin in November 2018 shows a capsule of the purified, prescription fish oil Vascepa. On Friday, Dec. 13, 2019, U.S. regulators approved expanded use of the medication for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. (Amarin via AP)
December 13, 2019 - 5:53 pm
TRENTON, N.J. (AP) — U.S. regulators on Friday approved expanded use of a fish oil-based drug for preventing serious heart complications in high-risk patients already taking cholesterol-lowering pills. Vascepa was approved years ago for people with sky-high triglycerides, a type of fat in blood...
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December 05, 2019 - 12:08 pm
SAN DIEGO (AP) — A company that claims to have the first drug to slow mental decline from Alzheimer's disease made its case to scientists Thursday, disclosing more results that may help explain why one study of the experimental medicine succeeded and another failed. Excitement and skepticism have...
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This undated photo provided by Acadia Pharmaceuticals Inc. shows a bottle of Nuplazid, a drug that was tested for treating psychosis related to dementia. If regulators agree, the drug could become the first treatment specifically for dementia-related psychosis and the first new medicine for Alzheimer's in nearly two decades. Results from a study on the drug were disclosed Wednesday, Dec. 4, 2019, at an Alzheimer's conference in San Diego. (Acadia Pharmaceuticals Inc. via AP)
December 04, 2019 - 8:53 pm
SAN DIEGO (AP) — A drug that curbs delusions in Parkinson's patients did the same for people with Alzheimer's disease and other forms of dementia in a study that was stopped early because the benefit seemed clear. If regulators agree, the drug could become the first treatment specifically for...
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This undated image provided by Novartis shows bottles of Novartis’s Adakveo. U.S. regulators have approved the new sickle cell disease medicine that can prevent extremely painful, dangerous “crises” in which misshapen blood cells clump together, reducing blood and oxygen flow. (Novartis via AP)
November 15, 2019 - 4:35 pm
U.S. regulators on Friday approved a new medicine that can help reduce extremely painful sickle cell disease flare-ups. The Food and Drug Administration approved Novartis AG’s Adakveo for patients 16 and older. The monthly infusion, which halves occurrences of sickle cell pain episodes, will carry...
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FILE - In this June 17, 2019, file photo, a cashier displays a packet of tobacco-flavored Juul pods at a store in San Francisco. Juul Labs said Monday, Sept. 30, 2019, that it will stop supporting a ballot measure to overturn an anti-vaping law in San Francisco, effectively killing the campaign. (AP Photo/Samantha Maldonado, File)
October 01, 2019 - 4:06 pm
SAN FRANCISCO (AP) — A campaign to defeat an industry-backed e-cigarette measure on San Francisco's ballot will push on despite the announcement by Juul Labs Inc. that it will stop financially supporting the proposal to overturn a city ban on e-cigarettes and vape product sales. The San Francisco...
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August 14, 2019 - 2:14 pm
TRENTON, N.J. (AP) — U.S. regulators have approved a new tuberculosis medicine that shortens and improves treatment for the hardest-to-treat cases, a worsening problem in many poor countries. It's the first TB drug developed by a nonprofit group, the TB Alliance, which was formed to come up with...
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This photo provided by Novartis shows their gene therapy medicine Zolgensma. U.S. regulators want to know why Novartis didn't disclose a problem with testing data until after they approved the Swiss drugmaker’s $2.125 million gene therapy. On Tuesday, Aug. 6, 2019, the Food and Drug Administration said the questionable data involves testing of the therapy, Zologensma, on animals, not on patients. (Novartis via AP)
August 06, 2019 - 6:24 pm
TRENTON, N.J. (AP) — U.S. regulators want to know why Novartis didn't disclose a problem with testing data until after the Swiss drugmaker's $2.1 million gene therapy was approved. The Food and Drug Administration said Tuesday the manipulated data involved testing in animals, not patients, and it's...
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