Tag: US FDA
Investigational antibiotic Zaynich clears drug-resistant infection in US cancer patient
Groundbreaking treatment marks the first use of Zaynich (Zidebactam/Cefepime-WCK 5222) under compassionate access
Curadev Pharma gets FDA nod for phase-1 study of its cancer...
The company has received US-FDA's 'Study May Proceed' letter for its Investigational New Drug Application of CRD3874, an IV-Administered STING Agonist for the treatment of advanced/metastatic solid cancers
Cognota receives US FDA approval for BP monitor device
The approval broadens Cognota’s portfolio; puts it in good stead with both hardware & IT solutions
Bharat Biotech’s partner seeks Covaxin nod in US for children between...
Covaxin, developed in India by Bharat Biotech, gained emergency approval from the World Health Organization (WHO) and has already been cleared for use in 17 countries......................
Advancements in digital technology critical to advancements in clinical trials
As per experts, the digital-enabled regulatory flexibility during the pandemic that had helped bring drugs faster to market needs to continue.....................
AliveCor brings world’s only six-lead, FDA-cleared personal ECG device to India
AliveCor’s entry into India comes at an opportune time when the public is cautioned to stay at home and the condition of most patients suffering from heart abnormalities has been worsening.....................
Sun Pharma to acquire Novartis’s Odomzo for global markets
Transaction gives Sun Pharma its first branded oncology product that has marketing approval in over 30 countries globally including US, Europe and Australia....
Mylan & Biocon announce first joint USFDA submission for biosimilar, Trastuzumab
Besides being an important milestone of Biocon and Mylan's joint global biosimilars program, the first biosimilar trastuzumab if approved by the top regulator.....