Drug Approval | May 20, 2023
Strides Puducherry facility receives EIR from USFDA
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
The audit is a pre-approval inspection for three products filed from the facility
Biocorp will receive an initial milestone payment this year
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