Articles written by linda a. johnson
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US approves 1st drug developed to prevent chronic migraines
TRENTON, N.J. (AP) — U.S. regulators Thursday approved the first drug designed to prevent chronic migraines. The Food and Drug Administration's action clears the monthly shot Aimovig (AIM'-oh-vig) for sale. It's the first in a new class of l...
FDA names drugmakers accused of blocking cheaper generics
TRENTON, N.J. (AP) — U.S. drug regulators are publicizing information on brand-name drugmakers that use what government officials call "gaming tactics" to block cheaper copycat versions. The Food and Drug Administration's new webpage names the m...
FDA approves 1st nonopioid drug to ease withdrawal symptoms
TRENTON, N.J. (AP) — Federal regulators on Wednesday approved the first nonopioid treatment to ease withdrawal from quitting addictive opioids. The U.S. Food and Drug Administration expedited approval of Lucemyra to help combat the U.S. opioid e...
New data: Americans filling far fewer opioid prescriptions
TRENTON, N.J. (AP) — The number of prescriptions for opioid painkillers filled in the U.S. fell dramatically last year, showing their biggest drop in 25 years and continuing a decline amid increasing legal restrictions and public awareness of the dan...
Insulin quality questions have diabetes experts scrambling
TRENTON, N.J. (AP) — Preliminary research suggesting that some diabetes patients may be injecting medicine that has partially disintegrated is causing concern even as serious questions are raised about the research itself. The study author, a pharmac...
Johnson & Johnson loses $10.7B after sweeping US tax changes
Johnson & Johnson posted a rare quarterly loss, a whopping $10.71 billion, due to a $13.6 billion charge related to last month's U.S. tax overhaul. While the loss was expected and the company's adjusted results beat Wall Street expectations, shares...
Hospital groups creating company to make cheap generic drugs
TRENTON, N.J. (AP) — Several major not-for-profit hospital groups are trying their own solution to drug shortages and high prices: creating a company to make cheaper generic drugs. The plan, announced Thursday, follows years of shortages of g...
US OKs 1st drug aimed at women with inherited breast cancer
U.S. regulators have approved the first drug aimed at women with advanced breast cancer caused by an inherited flawed gene. The Food and Drug Administration on Friday approved AstraZeneca PLC's Lynparza for patients with inherited BRCA gene...
Viagra goes generic: Pfizer to launch own little white pill
TRENTON, N.J. (AP) — The little blue pill that's helped millions of men in the bedroom is turning white. Drugmaker Pfizer is launching its own cheaper generic version of Viagra rather than lose most sales when the impotence pill gets its first g...
FDA approves diabetes drug that also helps with weight loss
TRENTON, N.J. (AP) — U.S. regulators on Tuesday approved a new diabetes drug that reduces blood sugar levels and also helps people lose significant weight. Danish drugmaker Novo Nordisk said the Food and Drug Administration approved its o...
AstraZeneca wins US approval for lymphoma drug
U.S. regulators have approved a new treatment for people with a rare form of non-Hodgkin lymphoma. The Food and Drug Administration on Tuesday granted accelerated approval to AstraZeneca PLC's Calquence for people with mantle cell lymphoma after...
FDA rejects muscular dystrophy drug, says it doesn't work
TRENTON, N.J. (AP) — The U.S. Food and Drug Administration has rejected an experimental drug for a common type of muscular dystrophy. The FDA's decision Wednesday was expected because the agency had said the drug didn't work in two key patient tests....
FDA OKs 2nd gene therapy for blood cancer; 1st for adults
TRENTON, N.J. (AP) — U.S. regulators have approved a second gene therapy for blood cancer. The one-time treatment is for aggressive lymphoma in adults. The Food and Drug Administration approved sales of the therapy from Kite Pharma on Wednesday. T...
FDA approves Lilly pill 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. Eli Lilly's Verzenio was approved Thursday by the Food and Drug Administration for women and men with what's...
FDA OKs continuous blood sugar monitor without finger pricks
U.S. regulators have approved the first continuous blood sugar monitor for diabetics that doesn't need backup finger prick tests. Current models require users to test a drop of blood twice daily to calibrate, or adjust, the monitor. The pain of...
FDA OKs Pfizer drug for rare, fast-killing type of leukemia
TRENTON, N.J. (AP) — The Food and Drug Administration has approved a new medicine for use against a rare, rapidly progressing blood cancer after other treatments have failed. The agency approved Pfizer Inc.'s Besponsa for patients with a type of a...
EpiPen maker finalizes settlement for government overcharges
TRENTON, N.J. (AP) — EpiPen maker Mylan has finalized a $465 million government agreement settling allegations it overbilled Medicaid for its emergency allergy injectors for a decade — charges brought after rival Sanofi filed a whistleblower law...
FDA OKs new drug to treat all forms of hepatitis C
U.S. regulators have approved the first drug to treat all forms of hepatitis C in as little as eight weeks. The pill combination from AbbVie Inc. was approved Thursday by the Food and Drug Administration for adults without significant cirrhosis, a ty...
Doctor told to stop marketing 3-person baby technique
U.S. regulators warned a New York fertility doctor to stop marketing an experimental procedure that uses DNA from three people — a mother, a father and an egg donor — to avoid certain genetic diseases. The doctor, John Zhang, used the technique to...
FDA OKs new Johnson & Johnson treatment for psoriasis
TRENTON, N.J. (AP) — U.S. regulators approved a new psoriasis drug from Johnson & Johnson Thursday, giving people with the itchy and painful condition another treatment option. Johnson & Johnson said that in one patient study, about seven in 10 p...
Novel leukemia treatment could be 1st US gene therapy
A treatment for a common childhood blood cancer could become the first gene therapy available in the U.S. A Food and Drug Administration advisory panel voted 10-0 on Wednesday in favor of the leukemia treatment developed by the University of...
Trying to keep brain sharp doesn't have to be costly
TRENTON, N.J. (AP) — While there's nothing you can do or take to ensure you won't get Alzheimer's disease, experts say there are some strategies that might help keep your brain sharp. And you don't need to dole out a lot of money to do it. "Does one...
Painkiller maker stops sales at FDA request because of abuse
The maker of opioid painkiller Opana ER is pulling the drug off the market at the request of federal regulators because it's being abused. Endo International PLC said Thursday it will voluntarily stop selling the pills, approved for use in patients...
FDA takes steps to boost generic competition, limit prices
The Food and Drug Administration said it's taking steps to boost the number of generic prescription drugs on the market in an effort to make medicines more affordable and to prevent price gouging. Copycat pills generally have been much cheaper than...
Merck says new type of cholesterol drug worked in big study
TRENTON, N.J. (AP) — Merck & Co. said Tuesday that a new type of cholesterol drug reduced heart attacks, deaths and other complications of heart disease in a huge, late-stage study. The positive result was a welcome surprise because three previous e...
