Government Agencies FDA

  • Oct 16- The U.S. Food and Drug Administration said https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm623540. htm? Talazoparib, a once-daily pill that Pfizer acquired with its $14 billion purchase of Medivation in 2016, is indicated for breast cancer triggered by mutation of BRCA genes, which accounts for 25-30 percent of hereditary...

  • Oct 16- The U.S. Food and Drug Administration said https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm623540. htm? utmtcam p a i g n= O n c o l o g y% 2 0 1 0% 2 F 1 6% 2 F 1 8% 2 0 t a l a z o p a r i b& u t m t m e d i u m= e m a i l& u t m t s o u r c e= E l o q u a& e l q T r a c k I d= 3 d 4 5 c 5 b a e 0 9 7 4 8 a a 8 2 b 2 6 d 0 d 4 8 f 2 c 1 5 b& e l q= 9 8 e 4 2 4 8 d 8 0 d 0 4 a b 2 9 0 7 c c e 3 6 9 a 7 c 5 1 7 6& e l q a i d= 5 5 1 3& e l q a t= 1& e l q C a m p a i g n I d= 4 4 2 9 on...

  • The Natural Cycles app uses an algorithm to predict fertility.

    In August, the FDA approved a mobile fertility app called Natural Cycles as a method of contraception. It's the first time that the U.S. has allowed a mobile app to advertise itself as a medical device that prevents pregnancy.

  • An FDA rule banned the sale of new e-cigarette products after August 2016 without regulatory approval. In September, Reuters reported that startups and big tobacco firms launched more than a dozen new high-nicotine e-cigarette products mimicking the popular Juul devices after the FDA imposed the deadline. He said the company notified the FDA in May that the...

  • An FDA rule banned the sale of new e-cigarette products after August 2016 without regulatory approval. In September, Reuters reported that startups and big tobacco firms launched more than a dozen new high-nicotine e-cigarette products mimicking the popular Juul devices after the FDA imposed the deadline. If the FDA determines the e-cigarettes were...

  • Oct 11- Trevena Inc's opioid injection for managing acute pain failed to win the backing of an advisory panel to the Food and Drug Administration on Thursday, against the backdrop of opioid addiction in the United States reaching epidemic proportion. The decision comes two days after FDA staff reviewers said overall assessment of the abuse-related data...

  • FDA staff reviewers said https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drug s/ A n e s t h e t i c A n d A n a l g e s i c D r u g P r o d u c t s A d v i s o r y C o m m i t t e e/ U C M 6 2 2 7 3 0. p d f overall assessment of the abuse-related data from studies suggests that Trevena's oliceridine has an abuse and overdose potential and could lead to physical...

  • FDA staff reviewers said https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drug s/ A n e s t h e t i c A n d A n a l g e s i c D r u g P r o d u c t s A d v i s o r y C o m m i t t e e/ U C M 6 2 2 7 3 0. p d f overall assessment of the abuse-related data from studies leads to the finding that Trevena's oliceridine has an abuse potential, overdose potential and...

  • Deadly Cdiff bacteria 

    Antibiotic-resistance infections are on the rise globally, resulting in a major health crisis. SciBac, a Silicon Valley start-up backed by Peter Thiel's Breakout Labs, has invented a microbiome pill to tackle superbugs.

  • Oct 8- Bausch Health Cos Inc, formerly Valeant Pharmaceuticals, said on Monday it received tentative U.S. approval to market its plaque psoriasis lotion, Bryhali. The company plans to launch the lotion in November after receiving final approval from the Food and Drug Administration, pending expiration of exclusivity for a related product, Bausch said in a...

  • Oct 5- Akcea Therapeutics Inc said on Friday its treatment, developed along with Ionis Pharmaceuticals, which targets a rare genetic disease was approved by the U.S. Food and Drug Administration. Tegsedi's approval in the United States comes nearly three months after its approval in Europe. Based on the U.S. approval of Tegsedi, Ionis will receive a $50 million...

  • Oct 4- Roche on Thursday said U.S. regulators approved expanded use of its drug Hemlibra to include almost all patients with hemophilia A, as the Swiss drugmaker increases its focus on diseases beyond cancer to help replace revenue from older products that have lost patent protection. The Food and Drug Administration cleared Hemlibra to treat adults, children...

  • Oct 4- Roche on Thursday said U.S. regulators approved expanded use of its hemophilia A drug Hemlibra to include nearly all patients, as the Swiss drugmaker increases its focus on diseases beyond cancer to help replace revenue from older products that have lost patent protection. The U.S. Food and Drug Administration cleared Hemlibra to treat adults, children...

  • Juul files patent complaint against 18 competitors

    CNBC's Aditi Roy reports on Juul filing a lawsuit against copycat competitors and how the e-cig company is starting to hurt big tobacco stocks.

  • Close-Up Of Sugar And Sweetener Packets In Container At Cafe

    A new study found that artificial sweeteners commonly found in low-sugar foods can harm the gut microbial system. US News & World Report has the story.

  • Oct 2- The U.S. Food and Drug Administration said on Tuesday it seized more than a thousand pages of documents from Juul Labs related to the company's sales and marketing practices after a surprise inspection, the latest clampdown on e-cigarette companies. The FDA said last month it was considering a ban on flavored e-cigarettes from Juul and others as the...

  • The FDA said last month it was considering a ban on flavored e-cigarettes from Juul and others as the agency grapples with an "epidemic" of youth e-cigarette use that threatens to create a new generation of nicotine addicts. The FDA also said it conducted inspections of several of Juul's contract manufacturing units earlier this year. "We've now released over...

  • Oct 2- The U.S. Food And Drug Administration said on Tuesday it seized documents from Juul Labs related to its sales and marketing practices after conducting a surprise inspection, in the agency's latest crackdown on e-cigarette companies. Last month, the FDA said it was considering a ban on flavored e-cigarettes from Juul and other companies as it grapples...

  • Oct 2- The U.S. Food And Drug Administration said on Tuesday it collected more than a thousand pages of documents from e-cigarette company Juul Labs after conducting an unannounced on-site inspection. Last month, the FDA said it was considering a ban on flavored e-cigarettes from Juul and other companies as it grapples with an "epidemic" of youth e-cigarette use...

  • Oct 1- The U.S. Food and Drug Administration on Monday approved Antares Pharma Inc's injectable drug to treat low testosterone levels in men, the company said, nearly a year after being rejected. The drug, however, comes with a boxed warning- the FDA's strongest- flagging risks of a rise in blood pressure that can cause major cardiovascular events.