AstraZeneca Plc raised its annual forecast, driven by strong demand for its blockbuster cancer drugs, and revealed a plan to ...

what information should be included in the plan, ways to request a waiver, and when and how it should be submitted to the FDA. For example, a DAP must be prepared for pivotal trials of a new drug ...

The president-elect has said he’ll let Robert F. Kennedy Jr. “go wild” on healthcare, while many expect a leadership change ...

A bumper crop of revisions, including a stronger drug benefit, means the Medicare plan you enrolled in for 2024 may not be ...

To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The Food and Drug Administration released a list of the medical device guidance documents it plans to work ...

From this realization, the Orphan Drug Act of 1983 was born. The plan was to target diseases ... Developing new drugs is a risky business—especially if a company fails to receive a patent.

In August, Trump said he wouldn't rule out taking away access to mifepristone, which was also mentioned by the policy ...

The recent FDA approval of Aucatzyl for treating adult patients with ... Additionally, Autolus Therapeutics’ strategic launch plan is poised to maximize market penetration, with 30 key centers ready ...

In 2025, if the plan has a deductible, the $35 will not count towards that amount, but it will count towards the $2,000 ...

Novavax’s plans for growth outside of its COVID program have been thrown into chaos after the FDA put two of the ... s plans to boost the value of the business are grounded “not only [in ...

Learn more about the business and the treatment ... Feedback from the FDA has informed Nanoscope's BLA submission plan, said Dr. Allen Ho, director of retina research and co-director of the ...

J&J filed a lawsuit Tuesday in the US District Court for the District of Columbia alleging the US Health Resources and ...