START is a pilot program newly launched jointly by the FDA CDER and CBER divisions to further accelerate the development of novel drug and biological p...
Bristol Myers Squibb announced that the European Commission (EC) has approved Opdivo®(nivolumab) in combination with cisplatin and gemcitabine ...
– Priority Review recognizes the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options...
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma FDA Priority Review gran...
Approximately one in five people worldwide have elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial inf...
The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with pa...
Atraverse Medical, a San Diego-based medical device company, announces the FDA clearance of its HOTWIRE™ radiofrequency (RF) guidewire, a novel devic...
Baxter International Inc. (NYSE: BAX), a pioneer in nutrition therapy, proudly announces the United States Food and Drug Administration (FDA) approval of a...
Moderna, Inc. received notification from the U.S. Food and Drug Administration (FDA) regarding a delay in the review process for its investigational respir...
BrioHealth Solutions, Inc., a medical technology company focused on developing innovative advanced heart failure solutions, announced it has received FDA I...
Beacon Biosignals, the leader in at-home EEG and computational neurodiagnostics, announced a collaboration with Takeda to conduct at-home sleep monitoring ...
The Company expects to initiate a Phase 1 clinical trial in PD in 2H 2024. NKGen Biotech, Inc. , a clinical-stage biotechnology company focused on the dev...
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) announces the launch of Mirabegron Extende...
Rilzabrutinib LUNA 3 phase 3 study met primary endpoint in immune thrombocytopenia Pivotal data from the first phase 3 study of a BTKi in immune thrombo...
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