Drug Approval | May 03, 2025
USFDA inspection at Concord Biotech’s API facility at Dholka
These observations are procedural in nature and none of them are related to data integrity
These observations are procedural in nature and none of them are related to data integrity
The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs
Breztri is an inhaled triple-combination therapy approved for the treatment of chronic obstructive pulmonary disease
The Subsidiary has received one inspectional observation in Form 483
Phesgo label expansion delivers on patients’ preference for at-home administration and is an important step in freeing up cancer care capacity in clinical settings
ekincare has raised a total funding of $22M since 2015 till date
The inspection concluded with 6 observations and none of them were related to Data Integrity
The positive opinions are based on applications submitted by Biosimilar Collaborations Ireland Limited
Distribution agreement enables FUJIFILM India to offer Spectra Logic advanced tape libraries and software solutions to enterprise customers and channel partners
Multiple studies show the combination potential of vedotin antibody-drug conjugates (ADCs) with pembrolizumab, including the first Phase 1 data in thoracic cancers for two first-in-class ADCs
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