WuXi Biologics、FDA査察をクリアし品質基準を強化 #FDA #無錫市 #GMP #WuXi_Biologics
WuXi BiologicsがFDAによるGMP査察を完了し、品質管理体制が一層強化されました。これにより、商用製品の供給体制が整いました。

permettere alle imprese di pianificare. La domanda ora è quanti prodotti simili siano già valutati come se potessero essere la prossima NAC. #RischioNormativo #FDA #NovelFood
Reste à savoir combien de produits similaires sont déjà valorisés comme s'ils pouvaient être la prochaine NAC. #RisqueRéglementaire #FDA #NovelFood
Die Frage ist nun, wie viele ähnliche Produkte bereits so bewertet werden, als könnten sie das nächste NAC sein. #Regulierungsrisiko #FDA #NovelFood
to new evidence and rules that are predictable enough for businesses to plan around. The question now is how many similar products are already being valued as if they could be the next NAC. #RegulatoryRisk #FDA #NovelFood
WuXi Biologics、FDA査察をクリアし品質基準を強化 #FDA #無錫市 #GMP #WuXi_Biologics
WuXi BiologicsがFDAによるGMP査察を完了し、品質管理体制が一層強化されました。これにより、商用製品の供給体制が整いました。
Long-term exposure to lead may result in “permanent damage to the central nervous system,” “learning disorders, developmental defects, and other longterm health problems.”
#FDA officials are urge consumers to check pantries and discard the recalled product.
www.fda.gov/safety/recal...
HHS asked if deceased-donor islets stay FDA biologics or become organs under OPTN. Comments due 9 Nov. Lantidra unchanged.
https://americapharmatoday.com/news/hhs-rfi-deceased-donor-islet-cells-type-1-diabetes?utm_source=bluesky&utm_medium=social&utm_campaign=hhs-islet-rfi-20260924
#FDA
FDA approved Amneal lanreotide (ANDA 218217) on 18 Sep. TE code AB. Reference: Somatuline Depot. CGT first marketing: 21 Sep.
https://americapharmatoday.com/news/fda-amneal-lanreotide-cgt-approval-somatuline?utm_source=bluesky&utm_medium=social&utm_campaign=amneal-lanreotide-cgt-20260918
#FDA
#FDA grants priority review to #lonvoguran #ziclumeran for #hereditary #angioedema. www.healio.com/news/...
FDA commissioner nominee Heidi Overton is ignoring the science on abortion drug: Mifepristone has passed every safety review. But Overton doesn’t seem to care. www.statnews.com/2026/09/25/h...
Refusing to challenge the boss, even on medical facts.
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#FDA #PublicHealth #Vaccines #SenateHearing
FDA approved Gazyva on 25 Sep to cut relapse risk in childhood nephrotic syndrome (age 2+, in remission). Boxed warning: hep B and PML.
FDA approved Atebrioz (zilurgisertib) on 25 Sep for FOP. Week 24 new bone: -3.2 cm3 on drug, +24.6 cm3 on placebo. Not coverage.
America had wiped out measles. Now babies are infected at birth as vaccination declines and more pregnant women become infected. www.nbcnews.com/health/healt...
#Project2025 #RFKjr #HHS #CDC #FDA #publichealth #vaccines #measles #Blues
📢 ICYMI: The #FDA has approved lirafugratinib (Lyrfigtu) for adults with previously treated unresectable, locally advanced or metastatic #cholangiocarcinoma harboring an FGFR2 gene fusion or other rearrangement.
Read more: targetedonc.com/view/fda-app...
🚨 According to #FDA data, there were 12,883 laboratory-confirmed illnesses in the largest #Cyclospora outbreak in U.S. history, accounting for nearly 90% of the 14,404 illnesses for all foodborne outbreaks this year.