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Drug Approval | April 07, 2024
Cipla Patalganga facility gets 6 USFDA observations
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
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.
Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment
Decision on EU marketing authorisation expected for momelotinib by early 2024
The sBLA is supported by a usability study which confirmed that individuals over 18 years of age could self-administer
Profit after tax (before exceptional items) up 23% to Rs 215 crores
Approval is for use in myelofibrosis patients with anaemia regardless of prior myelofibrosis therapy
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