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In March 2020, the Food and Drug Administration approved clinical trials for the Moderna COVID‑19 vaccine candidate, and in December, the vaccine, mRNA-1273, was issued an emergency use authorization in the United States. [35] [36] In 2022, it gained FDA approval both for the monovalent vaccine, Spikevax, and a bivalent booster. [37]
In 2010, Sun Pharmaceuticals of India acquired a majority stake in the company. [6] On 22 March 2012, the company's shares were re-listed on the NYSE. In 2013, Sun Pharmaceuticals attempted to buy the remaining shares in the company (it owns 69% stake), but as the company's financial performance improved, shareholders rejected the offer and the company remained publicly listed.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
A drug manufacturer inspection by the US Food and Drug Administration. The pharmaceutical industry is a medical industry that discovers, develops, produces and markets pharmaceutical goods such as medications and medical devices.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The US Food and Drug Administration (FDA) approved galcanezumab based on evidence from three clinical trials (Trial 1/NCT02614183, Trial 2/NCT02614196, and Trial 3/NCT02614261) in 2156 adults 18 to 65 years of age with chronic or episodic migraine headaches. [10]
The US Food and Drug Administration said it is tracking multiple cases of H5N1 bird flu in domestic and ... Raw milk is also sold as pet food in many states. Whether pre-made or made at home, vets ...
Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals , including biosimilars, must maintain consistent quality and clinical performance throughout their ...