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JD Supra: FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU
JD Supra· 3 hours agoENHERTU, which is now FDA-approved for five indications, is a specifically engineered HER2-directed antibody drug conjugate (“ADC”) discovered by Daiichi ...
One year after FDA approves over-the-counter birth control pill, advocates push for more access
West Virginia Watch via Yahoo News· 1 hour ago“My parents are immigrants from India, and it’s been over the counter there since my mom can...
Moderna Tumbles After The FDA Throws A Curveball On Its Second Product
Investor's Business Daily· 2 hours agoModerna Stock: Trailing Pfizer, GSK If approved, Moderna's RSV vaccine would be the third to hit the...
FDA Roundup: May 10, 2024
FOX 16 Little Rock· 2 hours agoOn Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices ...
FDA begins renewal review for Marlboro HeatSticks devices
Winston-Salem Journal· 9 hours agoThe styles were branded, respectively, as Marlboro HeatSticks, Marlboro Smooth Menthol HeatSticks...
Earnings call: Coherus BioSciences reports growth and pipeline progress By Investing.com
Investing.com· 1 hour agoCoherus BioSciences, Inc. (CHRS) announced positive developments in its first quarter 2024 earnings...
US FDA pushes decision on Moderna's RSV vaccine to end of this month
AOL· 11 hours agoThe FDA's move prolongs the wait for Moderna's second approved product, but the company said it remains on track to be reviewed by a panel of advisers at ...
FDA Issues Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
The National Law Review· 6 hours agoOn May 6, 2024, the U.S. Food and Drug Administration published its anticipated final rule...
Pharma Stock Roundup: PFE DMD Study Patient Death, FDA Panel Meet for LLY's Donanemab
Zacks via Yahoo Finance· 7 hours agoPfizer (PFE) reports the death of a participant in a mid-stage study of its Duchenne drug. An FDA...
FDA Issues Reminder for Medical Device Manufacturers to Ensure Data Reliability | JD Supra
JD Supra· 15 hours agoThe U.S. Food and Drug Administration (FDA or agency) recently issued a reminder to medical device manufacturers and sponsors regarding the use of third-party-generated data ...
