Codon

MARCH 24, 2024

In the case of semaglutide, those cells are Saccharomyces cerevisiae— also known as Baker’s yeast — engineered to secrete a peptide precursor that is later purified, chemically modified, packaged into an injectable or tablet form, and then shipped around the world. Continuing this method may not scale.

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Agency IQ

DECEMBER 1, 2023

Circuit’s ruling, FDA intends to assess any new data or information and, if it makes this same determination again, issue a new proposed rule to ban these devices. December 2023 Medical Devices; Quality System Regulation Amendments (Final Rule) FDA intends to harmonize and modernize the Quality System regulation for medical devices.

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New Drug Approvals

MAY 23, 2025

The combination therapy sulbactam/durlobactam was approved for medical use in the United States in May 2023. [1] REF [link] References ^ Jump up to: a b “FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria” U.S. Food and Drug Administration (Press release). 24 May 2023.

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New Drug Approvals

APRIL 27, 2025

13] [14] The first regulatory approval was granted in Germany in August 1999 to Madaus AG for Regurin 20 mg Tablets. [15] 15] :13 Madaus licensed the US rights to trospium chloride to Interneuron in 1999 and Interneuron ran clinical trials in the US to win FDA approval. [17] Retrieved 13 May 2016. billion in 2004. [23]

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New Drug Approvals

MAY 14, 2025

5] Rezafungin was approved for medical use in the United States in March 2023, [1] [6] [5] and in the European Union in December 2023. [2] 2] Rezafungin was approved for medical use in the European Union in December 2023. [3] PMID 38792732. ^ “Novel Drug Approvals for 2023” U.S. Food and Drug Administration (FDA).

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LifeSciVC

MAY 28, 2025

Here on this blog weve covered these topics a number of times in the past, with the March of the Lemmings in cancer in 2012 and I/O: The Strategic Supernova In Cancer Today in 2016. Many others have discussed this therapeutic crowding topic, so I wont belabor the points here.

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New Drug Approvals

MAY 22, 2025

4] The co-packaged combination sulbactam/durlobactam was approved for medical use in the United States in May 2023. [5] Retrieved 25 May 2023. ^ “Sulperazon” drugs.com. ^ “FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria” U.S. 46 (31): 89808987. 29 March 2023.

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Drug & Device Law

JANUARY 4, 2024

The Complaint further alleges that data collected and submitted in support of full (as opposed to emergency use) FDA approval demonstrated the misleading nature of earlier statements. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original). 115, 125 (2016).

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Drug & Device Law

DECEMBER 29, 2023

The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. The plaintiff failed to identify any method by which a generic (or any other) drug manufacturer could add a Prop 65 warning without deviating from FDA-approved labeling, thereby violating federal law. 13) McGee v.

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Drug & Device Law

NOVEMBER 7, 2022

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug. The defendant’s drug in Wilkins was the only FDA-approved medication for the treatment of a rare disease ( Fabry Disease ). Genzyme Corp. Genzyme Corp. ,

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