Last week, FDA Commissioner Marty Makary, MD, MPH, announced plans to officially lower the standard for how many clinical trials are needed to approve a new drug -- from the long-standing expectation ...
LIB Therapeutics has scored an FDA approval for its cholesterol-lowering, third-generation PCSK9 inhibitor, lerodalcibep-liga. The injected treatment, which will carry the commercial name Lerochol, is ...
The FDA expanded the indication of inebilizumab (Uplizna) to include generalized myasthenia gravis (gMG), Amgen announced Friday. The drug is now approved to treat gMG in adults who are ...
Dec 15 (Reuters) - The U.S. Food and Drug Administration has approved AstraZeneca (AZN.L), opens new tab and partner Daiichi Sankyo's (4568.T), opens new tab Enhertu in combination with Roche's (ROG.S ...
The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday. The voucher was granted to J&J for ...
LONDON, Dec 16 (Reuters) - The U.S. health regulator has approved GSK's (GSK.L), opens new tab add-on treatment for severe asthma, offering a less frequently dosed option, but rejected its use for ...
Over 40% of people taking Xenical achieved a 5% decrease in their starting body weight. Saxenda users achieved a 5% decrease in their body weight in more than 63% of cases. Eating a balanced diet and ...
The agency greenlit an oral version of the obesity drug Wegovy. By Dani Blum The Food and Drug Administration on Monday approved a pill version of the weight-loss injectable drug Wegovy, offering ...
RECOGNIZING AND IMPROVING KNOWLEDGE OF MEDICAL USES OF MARIJUANA AND CANNABIDIOL FOR PATIENTS AND DOCTORS: Today, President Donald J. Trump signed an Executive Order that will improve medical ...
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