Drug Approval | March 23, 2024
Briefs: Concord Biotech and Neuland Laboratories
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
Oscotec has successfully completed phase 2 study in patients with chronic ITP last year
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
Chlorpromazine Hydrochloride Injection is used to treat certain mental/mood disorders
PREVENAR offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine to help protect infants and children from the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU and globally
Acquisition broadens oncology pipeline with a portfolio of novel T-cell engagers including HPN328 (MK-6070), an investigational delta-like ligand 3 (DLL3) targeting T-cell engager
CRESEMBA receives seven years and six months of US market exclusivity for these pediatric indications
Pfizer to discuss regulatory submission with FDA, potentially leading to eighth indication for ADCETRIS
It is the first autotaxin inhibitor to be investigated in cancer patients
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