Search For "us food and drug administration"
US regulator conducts inspection of Piramal's unit in US
Updated : 3 years, 2 months ago IST
The company said it was preparing a detailed response to the observations, which will be submitted to the US FDA within the stipulated timelines. The company said it remains committed to maintaining the highest standards of compliance and will work closely with the agency to address all the
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Aurobindo Pharma arm receives regulator's nod to make, market Azacitidine
Updated : 3 years, 2 months ago IST
The product is expected to be launched this month, according to the statement from Aurobindo Pharma
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US FDA clears passage for pharmacies to dispense abortion pills
Updated : 3 years, 2 months ago IST
The US Food and Drug Administration has, for the first time cleared a passage for certified pharmacies to dispense abortion pills in the United States, Al Jazeera reported on Tuesday.
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US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Ina
Updated : 3 years, 2 months ago IST
Mumbai (Maharashtra) [India], January 3 (ANI/PRNewswire): Datar Cancer Genetics announced today that the US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its 'TriNetra™-Glio', a blood test to help in the diagnosis of brain tumors. This is the thir
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Glenmark gets US drug regulator's nod for high BP medicine
Updated : 3 years, 2 months ago IST
Glenmark's Nicardipine Hydrochloride capsules of 20 mg and 30 mg will be distributed in the US by Glenmark Pharmaceuticals US, according to a statement from Glenmark.
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Alembic Pharma gets US regulator final nod for skin ointment - Desonide Cr
Updated : 3 years, 3 months ago IST
According to a statement from the Vadodara-headquartered pharma firm, the ANDA was filed by Aleor Dermaceuticals (Aleor) which was amalgamated with Alembic. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Desonide Cream, 0.05 per cent, of Padagis U
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Sun Pharma, SPARC sign licence agreement for sale of seizure drug for inje
Updated : 3 years, 4 months ago IST
SPARC submitted a new drug application (NDA) to the US Food and Drug Administration (US FDA) for this product for the treatment of seizures in newborns in February 2022, according to Sun Pharma statement shared with stock exchanges.
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Zydus gets USFDA's final nod to market antifungal Micafungin for injection
Updated : 3 years, 4 months ago IST
Zydus Lifesciences has received approval from US Food and Drug Administration to market Micafungin.
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Magnum receives USFDA 510k clearance for its surgical masks
Updated : 3 years, 6 months ago IST
New Delhi [India], August 26 (ANI/SRV): Magnum, one of the largest mask manufacturers from Mumbai, which has been in this industry for the last 29 years has recently received the US Food and Drug Administration (FDA) 510 (k) clearance, which is an approval by the United States government tha
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Study discovers drug for Alzheimer's disease without inflammatory side eff
Updated : 3 years, 7 months ago IST
Daejeon [South Korea], August 4 (ANI): The US Food and Drug Administration recently approved Aduhelm, a monoclonal antibody that targets amyloid beta (A), as the first Alzheimer's disease treatment (AD). Its impact on cognitive improvement, however, is controversial.
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Researchers find drug for Alzheimer's disease without inflammatory side ef
Updated : 3 years, 7 months ago IST
Daejeon [South Korea], August 4 (ANI): Aduhelm, a monoclonal antibody that targets amyloid beta (A), was recently found by the US Food and Drug Administration as the first treatment for Alzheimer's disease (AD). However, its impact on cognitive improvement is still debatable.
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Scalp cooling is proving to be successful in preventing hair loss due to c
Updated : 3 years, 7 months ago IST
Ahmedabad (Gujarat) [India], July 25 (ANI/PNN): Losing hair is one of the most painful experiences of cancer patients undergoing chemotherapy. It is especially the case for women patients. But not any longer; Scalp cooling is an innovative method that has helped thousands of cancer patients
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