Drug Approval | April 28, 2024
Jubilant Pharmova announces completion of USFDA audit of Radiopharmaceuticals manufacturing facility at Montreal
The USFDA has issued 5 observations pursuant to the completion of audit
The USFDA has issued 5 observations pursuant to the completion of audit
Breakthrough Therapy designation for pain associated with DPN granted by FDA
Submission based on results from pivotal phase III trial showing all primary endpoints met
Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine
ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk.
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
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
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
India has reached to nearly 6,000 bio-startups from 50 in the past 10 years
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