FDA names longtime cancer scientist Pazdur to lead drug center

The Food and Drug Administration has named a longtime regulator of cancer medications to lead the agency’s drug center ...

I went through the wringer to get menopause drugs — what we need as FDA changes ‘black box’ warning

The FDA recently announced it would remove “misleading” black box warnings for drugs that use hormones to treat menopause.
ExecutiveGov

FDA Names Richard Pazdur as Director of Center for Drug Evaluation, Research

The Food and Drug Administration has appointed Richard Pazdur, the founding director of the agency’s Oncology Center of ...
Healio

FDA grants 510(k) clearance for TMS as adjunctive for major depressive disorder in young people

The FDA has granted 510(k) clearance and a label expansion for a transcranial magnetic stimulation device to treat patients ...
Health on MSN

4 Things to Know About Hormone Therapy As FDA Removes Black Box Warning

The FDA is removing any mention of risks related to breast cancer, heart disease, and dementia on hormone therapy products ...
Medscape

Checkpoint Inhibitor Prices Dropped Marginally Over Decade

A recent analysis reveals that monthly prices of checkpoint inhibitors decreased only a small amount over a decade.
BioSpace

Billions More in M&A, Another Bidding War and More FDA Drama

Merck has made a $9.2 billion play for Cidara, and there’s another bidding war afoot, this one for sleep biotech Avadel. Meanwhile, Rick Pazdur has taken the helm at CDER while tensions run high ...

FDA to Speed Reviews With Better Communication and a Hiring Spree

The US Food and Drug Administration is rolling out a new program to speed up drug reviews by emphasizing clearer, more frequent communication with companies, aided by a surge of new hires.
Scientific American

The Abortion Pill Is Safe. Scientists Fear an FDA Investigation Will Ignore Science

Secretary of Health and Human Services Robert F. Kennedy, Jr., recently announced that the U.S. Food and Drug Administration will launch a review of the safety of the abortion pill, mifepristone.
BioSpace

Signs of Frustration Build Between Kennedy and FDA Commissioner Makary

Top Trump administration officials have taken issue with Marty Makary’s management style, pointing to infighting between his ...

Research compares how GLP-1s impact the heart, kidneys of veterans with type 2 diabetes

Clinical pharmacist and investigator Catherine “Katie” Derington, PharmD, MS, led research that suggests liraglutide, semaglutide, and dulaglutide may be equally safe options for patients with type 2 ...
The American Journal of Managed Care

Global Gaps in Drug Access After FDA Approval: Insights From New Study and Ethics Guidelines

Lower middle- and low-income countries are less likely to receive market authorization for drugs that were trialed within their state and approved by the FDA within 5 years of approval when compared ...