Drug Approval | May 07, 2024
Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility
With this, for all our USFDA facilities, EIRs are in place
With this, for all our USFDA facilities, EIRs are in place
Submission based on results from pivotal phase III trial showing all primary endpoints met
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva
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This facility manufactures APIs & formulations of oncology and non-oncology products.
Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Application based on results from the TROPION-Breast01 Phase III trial
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+
It is the first autotaxin inhibitor to be investigated in cancer patients
The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.
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