Drug Approval | July 24, 2024
USFDA successfully inspects Carbogen Amcis’s manufacturing sites in Neuland and Aarau
The inspections concluded with no Form 483 observations or significant critical findings
The inspections concluded with no Form 483 observations or significant critical findings
The integrated company delivers a broad portfolio of over 30,000 lab products across microscopy, histology, and other research areas
Phase III ARANOTE trial met primary endpoint, significantly increasing radiological progression-free survival (rPFS) with NUBEQA plus androgen deprivation therapy (ADT) compared to placebo plus ADT
The innovative ‘Street Safe’ Rapid Testing Kit should be provided to all vendors attending the Food Safety and Certification (FoSTaC) trainings to ensure that safe food is used by the street food vendors across the country
Multidisciplinary central team deployed to assist Gujarat with epidemiological, environmental, and laboratory investigations of AES cases
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
This transaction is the third acquisition by three different Japanese players in this segment
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
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€ 6.6 million investment at Nantong site expands production capabilities for cell culture media
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
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