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...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...
...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...
...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...
...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....
...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....
...on behalf of the Food and Drug Administration....
...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....
...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...
...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...
...The US Food and Drug Administration on Friday approved the world’s first ever two gene therapies to treat patients with sickle cell disease....
...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....
...Part of the aim of the metformin trial is to persuade the US Food and Drug Administration to approve ageing as an “indication”, to signify that it can be “treated”....
...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....
...The US Food and Drug Administration gave the greenlight for Beqvez as a treatment for patients with moderate-to-severe haemophilia B, which affects 38,000 people worldwide, Pfizer said....
...Novo Nordisk’s Wegovy medication, which this month received US Food and Drug Administration approval to help reduce heart attack and stroke risk in patients with a history of cardiovascular problems, can...
...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....
...The abortion pill case heard on Tuesday by the Supreme Court stems from a legal challenge filed by a group of anti-abortion advocates alleging the US Food and Drug Administration did not properly approve...
...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...
...The US Food and Drug Administration recently approved the first-ever drug designed specifically for the most common liver disease, metabolic dysfunction-associated steatohepatitis or mash, developed by Madrigal...
...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...
...A Humira biosimilar from Teva Pharmaceuticals working with Alvotech earlier this year became the first drug that the US Food and Drug Administration granted interchangeable status, which lets pharmacists...
...Brian Lian, Viking’s chief executive, said the company would meet regulators at the US Food and Drug Administration to assess next steps by the middle of the year....
...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....
...The case before the high court began with a legal challenge filed in Texas federal court by a group of anti-abortion advocates alleging the US Food and Drug Administration did not properly approve the drug...
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