Search For "fda"
Drug regulatory body initiates probe after US FDA flags contamination risk
Updated : 3 years, 1 month ago IST
After the US regulator Food and Drug Administration warned consumers "not to purchase or use EzriCare Artificial Tears due to potential contamination", the Central Drugs Standard Control Organization (CDSCO) under the Union Health ministry and the Tamil Nadu State Drug Controller have ini
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Alma, a Sisram Medical company, announces the launch of Alma Duo - an adva
Updated : 3 years, 1 month ago IST
Nuremberg [Germany], January 26 (ANI/PRNewswire): Alma, one of the top three global leaders of energy-based medical and aesthetics solutions, has announced the launch of its new sexual wellness product - Alma Duo.
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MedAlliance leads US Sirolimus DEB race: First US Patient enrolled into SE
Updated : 3 years, 1 month ago IST
Geneva [Switzerland], January 26 (ANI/PRNewswire): The first US patient has been enrolled at MedStar Washington Hospital Center in the SELUTION4ISR study evaluating SELUTION SLR™ to support FDA approval. This milestone follows Investigational Device Exemption (IDE) approval in the US i
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Granules gets US drug regulator's nod for Amphetamine capsules
Updated : 3 years, 1 month ago IST
The product will be manufactured at Granules manufacturing facility in Chantilly, Virginia, and is expected to be launched shortly, according to a company statement shared with stock exchanges.
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VCare's Hair Transplantation Ensures To Completely Reverse Baldness
Updated : 3 years, 2 months ago IST
New Delhi [India], January 18 (ANI/PNN): Activated Follicular Transplant (AFT) is a unique patented trademark hair transplantation procedure offered at VCare. It ensures to reverse of baldness and gives people with baldness new hope.
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Zydus gets US FDA final nod for Febuxostat tablets for treating high uric
Updated : 3 years, 2 months ago IST
According to the statement from Zydus, Febuxostat tablets are indicated to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol.
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Sun Pharma launches novel drug Palbociclib for treatment of advanced breas
Updated : 3 years, 2 months ago IST
According to Sun Pharma, Palbociclib is approved by the US Food and Drugs Administration (FDA), European Medicines Agency (EMA) and Central Drugs Standard Control Organisation (CDSCO) in combination with hormonal therapies for patients with hormone receptor-positive, human epidermal growth f
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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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MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE
Updated : 3 years, 2 months ago IST
Geneva [Switzerland], January 11 (ANI/PRNewswire): SELUTION SLR™, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of coronary de novo lesions.
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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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Curadev Pharma announces the formation of its Clinical Advisory Group
Updated : 3 years, 2 months ago IST
Noida (Uttar Pradesh) [India], January 4 (ANI/PRNewswire): Curadev Pharma has created a Clinical Advisory Group (CAG) comprising eminent oncologists to provide guidance in the design and execution of immune-oncology clinical trials with CRD3874, its lead non-nucleoside, allosteric small mole
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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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