The FDA has approved a new formulation of methotrexate designed as an oral solution for pediatric patients. The agency has also recently introduced age restrictions for codeine and tramadol for children under age 12, citing their risks for slowed or difficult breathing and death…
A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
The FDA has declined to approve baricitinib to treat rheumatoid arthritis, citing the need for more data on dosing and safety…
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
In March, an FDA advisory committee voted that the risks of Opana ER to public health outweigh its benefits as a chronic pain treatment…
(Reuters)—The U.S. Food and Drug Administration (FDA) has raised concerns over quality controls at a Mylan NV manufacturing plant in India, according to a warning letter from the agency dated April 3. India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of…
(Reuters)—The U.S. Food and Drug Administration needs Corbus Pharmaceuticals to show positive data from only one late-stage study on its experimental treatment for scleroderma to support a marketing application, the company said. Corbus said on Wednesday it expects to start the study on 270 patients in the fourth quarter and that it was in talks…
(Reuters)—President Donald Trump’s nominee to lead the U.S. Food and Drug Administration, Dr. Scott Gottlieb, was questioned about his ties to the pharmaceutical industry by Democrats on a key Senate committee on Wednesday ahead of a vote on whether to advance his nomination for a vote by the full Senate. Gottlieb, 44, is a former…
WASHINGTON (Reuters)—U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump’s plan to dramatically cut regulations governing…
Brodalumab has received FDA approval for treating plaque psoriasis in adults, with a Boxed Warning against prescribing it for patients with a history of suicidal thoughts or behavior…