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Amazon.com
Amazon threatened with legal action over sales of ‘unapproved’ drugs
...The Food and Drug Administration wrote to Amazon chief executive Andy Jassy in a letter this month complaining that drugs that supposedly treated molluscum contagiosum, a skin condition that causes lesions...
August 30, 2023
News in-depthDementia
Alzheimer’s drug Leqembi falls short of blockbuster status in faltering US rollout
...Leqembi, priced at $26,500 a year, was the first drug with a black-box warning — the most severe designation about possible side effects — to be granted full approval by the US Food and Drug Administration...
April 22, 2024
FT Live
FTWeekend Festival: U.S. edition
Where the Financial Times weekend paper comes to life
Saturday, 4 MayThe REACH, at the Kennedy Center for the Performing Arts, F Street Northwest, Washington, DC, USA
Eli Lilly & Co
US regulator delays decision on Eli Lilly’s Alzheimer’s drug donanemab
...A decision from the US Food and Drug Administration on Eli Lilly’s donanemab drug was originally due by the end of the first quarter but the breakthrough medicine will now be subject to a further review...
March 8, 2024
Royal Philips NV
Philips halts sleep apnoea device sales in US after FDA deal
...and Drug Administration....
January 29, 2024
Biotech
Investors pile into psychedelic drug start-ups tackling mental health
...These will be the first results from a study designed around landmark US Food and Drug Administration guidelines for researching psychedelics that were outlined last year, a decision that encouraged investors...
February 10, 2024
Vivek Ramaswamy
Vivek Ramaswamy’s FDA ‘corruption’ claims disavowed by Roivant
...US biotech company Roivant Sciences has moved to distance itself from its founder, Vivek Ramaswamy, after the Republican presidential contender alleged that the US Food and Drug Administration was “corrupt...
September 3, 2023
FT Live
US Pharma and Biotech Summit
Strategies for innovation, pricing and access
Thursday, 16 MayNew York, NY, USA
News updates from March 8: US adds 275,000 jobs in February; Bitcoin and gold touch new highs
US regulators delay decision on Eli Lilly’s Alzheimer’s drug
...A decision on Eli Lilly’s donanemab drug from the US Food and Drug Administration was originally due by the end of the first quarter, but the medicine will now be subject to a further review by an advisory...
March 8, 2024
LexRoyal Philips NV
Philips: suspect device prompts night terrors for investors Premium content
...On Tuesday, the US Food and Drug Administration issued a “device safety communication” about DreamStation 2. Philips launched this gadget three years ago to replace the discredited predecessor....
November 29, 2023
Covid-19 vaccines
FDA approves new Covid-19 boosters from Pfizer and Moderna
...and Drug Administration said on Monday....
September 11, 2023
Drug prices
US regulator approves Florida bid to import medicines from Canada
...The US Food and Drug Administration will allow Florida to import medicines from Canada, making it the first state to capitalise on rules designed to lower the cost of prescription drugs....
January 5, 2024
Tobacco
FDA issues ban on RJ Reynolds menthol-flavoured vapes in US
...The Food and Drug Administration said on Thursday that it had issued marketing denial orders for six vaping products sold by BAT-owned RJ Reynolds Vapor Company under its Vuse Alto brand....
October 12, 2023
Eli Lilly & Co
Eli Lilly weight-loss drug found to address sleep apnoea in trial
...Eli Lilly said that it plans to submit the results to the US Food and Drug Administration and other medicine regulators worldwide to seek approval for tirzepatide as a sleep apnoea treatment beginning this...
April 17, 2024
Pharmaceuticals sector
Approval for Eli Lilly obesity drug sets up rival to Wegovy
...The US Food and Drug Administration and the UK’s Medicines and Healthcare products Regulatory Agency said patients in clinical trials of Lilly’s tirzepatide had seen “significant” weight loss compared with...
November 9, 2023
Dementia
US regulators approve first drug to slow progression of Alzheimer’s
...The US Food and Drug Administration has approved the first Alzheimer’s drug that can slow the progression of the neurodegenerative disease, paving the way for millions of American patients to access the...
July 6, 2023
News updates from October 12: US inflation hotter than expected in September, FCA bans Staley
Sales of most popular US vape halted by FDA
...The Food and Drug Administration said on Thursday that it had issued marketing denial orders for six vaping products sold by BAT-owned RJ Reynolds Vapor Company under its Vuse Alto brand....
October 12, 2023
FT Live
Global Pharma and Biotech Summit
Driving life sciences innovation in a disrupted world
Tuesday, 5 NovemberIn-Person & Online Conference
News updates from December 8: US adds 199,000 jobs in November, UK competition watchdog examining Microsoft-OpenAI ties
US drug regulator approves Crispr gene editing therapy
...The US Food and Drug Administration on Friday approved the world’s first ever two gene therapies to treat patients with sickle cell disease....
December 8, 2023
News updates from November 8: Iger pledges another $2bn in Disney cost cuts, Draghi delivers downbeat EU forecast
US approves Eli Lilly’s injectable weight loss drug
...The Food and Drug Administration on Wednesday approved Zepbound for obese and overweight adults. About 70 per cent of adults in the US are obese or overweight, the FDA said....
November 8, 2023
Medical science
Experimental gene therapy tests US system of fast-track drug approval
...But the decision, which is expected to be taken by the US Food and Drug Administration by June 22, is controversial as some health experts warn that there is not enough evidence the therapy works....
June 19, 2023
News updates from October 6: US jobs growth surges, Pioneer shares soar on ExxonMobil deal reports
Philips shares fall nearly 10% after FDA criticism of product recall
...Philips shares plunged nearly 10 per cent on Friday after the US Food and Drug Administration said steps taken by the company on the recall of its sleep apnoea and breathing machines were inadequate....
October 6, 2023
Reproductive rights
US regulator approves first over-the-counter birth control pill
...The Food and Drug Administration on Thursday approved Opill, an oral contraceptive made by the Irish-American pharmaceutical group Perrigo, for non-prescription use....
July 13, 2023
Reckitt Benckiser Group PLC
US regulator warns Reckitt on baby formula manufacturing standards
...The US Food and Drug Administration also sent warning letters to ByHeart and Perrigo, two other manufacturers that recalled batches of formula because of the potential presence of the bacteria....
August 31, 2023
Pharmaceuticals sector
Pharma groups warn of supply crunch over China spying law
...Meanwhile, official data seen by the Financial Times shows some US Food and Drug Administration inspectors have been refused entry to Chinese production sites since the pandemic....
April 21, 2024
Medical science
US regulators approve first human pill derived from faecal matter
...Seres said approval of the first oral microbiota therapy by the US Food and Drug Administration would provide patients with new tool to fight C. difficile infections, which cause inflammation of the colon...
April 26, 2023
GSK PLC
GSK readies for pivotal ruling in Zantac cases
...The US Food and Drug Administration and the European Medicines Agency recommended suspension of ranitidine products and the FDA asked all manufacturers to withdraw their products based on the drug....
April 24, 2024
News updates from September 12: BP CEO Looney to resign, Birkenstock files for Wall Street IPO
US drug regulator approves updated Covid-19 jabs
...and Drug Administration said on Monday....
September 11, 2023

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