Dr. Reddy’s Laboratories RDY and partner, Alvotech ALVO, announced the FDA’s acceptance of a regulatory filing, seeking the ...

The FDA has approved Purified Cortrophin Gel (repository corticotropin injection USP) in a prefilled syringe presentation.

The Food and Drug Administration (FDA) announced a new initiative Tuesday titled “Operation Stork Speed” aimed at reviewing ...

Acting Administrator Derek MaltzDrug Enforcement AdministrationATTN: DEA Federal Register Representative8701 Morrissette Dr.Springfield, VA 22152Re: Docket No. DEA-407 Special Registrationsfor Telemed ...

Dr. Reddy’s Laboratories (RDY) and Alvotech (ALVO) announced that the U.S. FDA has accepted a Biologic License Application submission for AVT03. Read more here.

“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,” said Milan ...

Despite a federal judge ordering deportation flights of Venezuelans to cease, video shows more deportees arriving in El Salvador.

These days, when he’s on the streets, it’s often with voter registration forms in hand — part of a growing movement of people working to expand the political power of an often-ignored bloc of ...

A change driven by a risk to the health and safety of Canadians will take priority over others. The amendment and notification form includes a section to note whether the change was in response to a ...

LOS ANGELES -- A little-known Chinese company has made a drug that beats the world's biggest-selling medicine, said a CNN report on Tuesday. "China's DeepSeek shocked the world by delivering ...

Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...

There is also a supplementary section to the form for managers where more than one location is included in the application. You will need to use one copy of this section for each additional location.