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FDA begins renewal review for Marlboro HeatSticks devices
Winston-Salem Journal· 1 day agoThe FDA began Friday its scientific review for the IQOS 2.4 and 3.0 systems holders and chargers and...
Pharma Stock Roundup: PFE DMD Study Patient Death, FDA Panel Meet for LLY's Donanemab
Zacks via Yahoo Finance· 1 day agoPfizer (PFE) reports the death of a participant in a mid-stage study of its Duchenne drug. An FDA...
Freyja wins FDA clearance for VereSee device
Medical Device Network via Yahoo Finance· 1 day agoEarly-stage medical device company Freyja Healthcare has received 510(k) clearance from the US Food and Drug Administration (FDA) for its VereSee device,...
Moderna says FDA delaying decision on RSV vaccine approval, shares fall
Investing.com· 1 day agoModerna says FDA delaying decision on RSV vaccine approval, shares fall
PharmaTher Announces Assigned FDA Approval Goal Date of its Priority Original Abbreviated New Drug...
Digital Journal· 1 day agoFood and Drug Administration (the “FDA”) and assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. As announced by the Company on April ...
One year after FDA approves over-the-counter birth control pill, advocates push for more access
Michigan Advance via Yahoo News· 1 day ago“My parents are immigrants from India, and it’s been over the counter there since my mom can...
Unpacking Averages: Assessing the Products Included in FDA's Voluntary Malfunction Summary Reporting...
The National Law Review· 3 days agoAt the end of 2022, FDA published a draft guidance on Voluntary Malfunction Summary Reporting (VMSR)...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 5 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
U.S. Senators Amy Klobuchar and Tammy Duckworth Introduce Legislation to Raise Food Safety and...
Sierra Sun Times· 2 hours agoHeavy metals such as lead, arsenic, cadmium, mercury or other contaminants, if regularly consumed by...
Moderna Tumbles After The FDA Throws A Curveball On Its Second Product
Investor's Business Daily· 20 hours agoThe news pushes back the potential approval of the vaccine for respiratory syncytial virus by...