Product approvals

FILE - In this Thursday, Nov. 10, 2016 file photo, test cigarettes burn in a smoking machine at the Centers for Disease Control and Prevention in Atlanta. A decade after President Barack Obama signed the Family Smoking Prevention and Tobacco Control Act into law in 2009, health advocates say the Food and Drug Administration has yet to put in place the most sweeping changes envisioned by Congress. (AP Photo/Branden Camp)
1010 WINS Newsroom
August 29, 2019 - 1:12 pm
WASHINGTON (AP) — It seemed like a new era in the half-century battle against the deadly toll of tobacco: U.S. health officials for the first time would begin regulating cigarettes, chew and other products responsible for a half-million American deaths annually. "The decades-long effort to protect...
Read More
This undated photo provided by the TB Alliance in August 2019 shows the drug pretomanid. On Wednesday, Aug. 14, 2019, the U.S. Food and Drug Administration approved pretomanid, the first tuberculosis drug developed by a nonprofit group. The TB Alliance was formed to come up with better treatments for the pulmonary disease. (TB Alliance via AP)
August 14, 2019 - 4:51 pm
TRENTON, N.J. (AP) — U.S. regulators Wednesday 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 from a nonprofit group, the TB Alliance. Formed to come up with better...
Read More
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 - 6:51 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...
Read More
FILE - This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. The FDA has approved the first generic copies of a popular, pricey pill for nerve pain. The agency on Monday, July 22, 2019, said it approved nine generic versions of Pfizer Inc.’s Lyrica. (AP Photo/Jacquelyn Martin, File)
July 22, 2019 - 3:15 pm
TRENTON, N.J. (AP) — The U.S. Food and Drug Administration has approved the first generic copies of a popular, pricey pill for nerve pain. The agency on Monday said it approved nine generic versions of Pfizer Inc.'s Lyrica. It is also used for seizures and fibromyalgia, a condition that causes...
Read More
In this June 13, 2019, photo released by Xinhua News Agency, guests, from left, Yi Huiman, chairman of China Securities Regulatory Commission, Liu He, vice premier, Li Qiang, top party official of Shanghai, and Ying Yong, Shanghai's mayor, celebrate the launch of the SSE STAR Market, previously referred to as the Shanghai science and technology innovation board in Shanghai. Trading is expected to start Monday, July 22, 2019 on the Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. (Fang Zhe/Xinhua via AP)
July 20, 2019 - 8:45 pm
BEIJING (AP) — Trading starts Monday on a Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. Regulators have approved 25 companies in information technology and other fields seen by communist leaders as a...
Read More
In this June 13, 2019, photo released by Xinhua News Agency, guests, from left, Yi Huiman, chairman of China Securities Regulatory Commission, Liu He, vice premier, Li Qiang, top party official of Shanghai, and Ying Yong, Shanghai's mayor, celebrate the launch of the SSE STAR Market, previously referred to as the Shanghai science and technology innovation board in Shanghai. Trading is expected to start Monday, July 22, 2019 on the Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. (Fang Zhe/Xinhua via AP)
July 18, 2019 - 1:25 am
BEIJING (AP) — Trading starts Monday on a Chinese stock market for high-tech companies that play a key role in official development plans that are straining relations with Washington. Regulators have approved 25 companies in information technology and other fields seen by communist leaders as a...
Read More
This image provided by Amag Pharmaceuticals in June 2019 shows packaging for their drug Vyleesi. The medication OK'd Friday, June 21, 2019 by the U.S. Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men in the late 1990s. (Amag Pharmaceuticals via AP)
June 21, 2019 - 6:20 pm
WASHINGTON (AP) — U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours. The medication OK'd Friday by the Food and Drug Administration is only the second approved to...
Read More
In this Monday, June 17, 2019, photo, Joshua Ni, 24, and Fritz Ramirez, 23, vape from electronic cigarettes in San Francisco. San Francisco supervisors are considering whether to move the city toward becoming the first in the United States to ban all sales of electronic cigarettes in an effort to crack down on youth vaping. The plan would ban the sale and distribution of e-cigarettes, as well as prohibit e-cigarette manufacturing on city property. (AP Photo/Samantha Maldonado)
June 18, 2019 - 8:42 pm
SAN FRANCISCO (AP) — San Francisco supervisors moved a step closer Tuesday to becoming the first city in the U.S. to ban all sales of electronic cigarettes to crack down on youth vaping. Supervisors unanimously approved a ban on the sale and distribution of e-cigarettes. They also endorsed a ban on...
Read More
FILE - In this March 26, 2019, file photo, a baggage handler waits for luggage to arrive to sort and deliver to passengers at Dulles International Airport in Dulles, Va. The Transportation Security Administration has changed its cannabis policy to allow passengers to travel with some forms of CBD oil and a drug derived from marijuana that has been approved by the Food and Drug Administration. (AP Photo/Cliff Owen, File)
May 28, 2019 - 7:59 pm
WASHINGTON (AP) — The Transportation Security Administration has changed its cannabis policy to allow passengers to travel with some forms of CBD oil and a drug derived from marijuana that has been approved by the Food and Drug Administration. All forms of marijuana were previously prohibited in...
Read More
This photo provided by Novartis shows Zolgensma. The one-time gene therapy developed by Novartis, Zolgensma, will cost $2.125 million. It treats a rare condition called spinal muscular atrophy, or SMA, which strikes about 400 babies born in the U.S. each year. The therapy, given in a one-hour infusion, was approved for children under age 2 and will be available within two weeks. (Novartis via AP)
May 24, 2019 - 2:35 pm
U.S. regulators have approved the most expensive medicine ever, for a disorder that destroys a baby's muscle control and kills nearly all of those with the most common variant of the disease within a couple years. The treatment is priced at $2.125 million. Out-of-pocket costs for patients will vary...
Read More

Pages