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Results For "FDA"

2439 News Found

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules
Drug Approval | November 23, 2021

Alembic receives tentative U.S. FDA approval for Dabigatran Etexilate capsules

Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE)


FDA grants Theradaptive Breakthrough Medical Device designation
Medical Device | November 22, 2021

FDA grants Theradaptive Breakthrough Medical Device designation

Theradaptive's regenerative implants are best-in-class and are designed to permit precise tissue regeneration for a variety of tissue types and clinical indications


U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer
Drug Approval | November 20, 2021

U.S. FDA grants breakthrough designation to Datar’s blood test to detect breast cancer

It is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years


U.S. FDA allows Pfizer and Moderna booster doses for all
News | November 20, 2021

U.S. FDA allows Pfizer and Moderna booster doses for all

This is a shot in the arm for the vaccine manufacturers


U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism
Drug Approval | November 20, 2021

U.S. FDA approves first drug to improve growth in kids with most common form of dwarfism

Achondroplasia is a genetic condition that causes severely short stature and disproportionate growth


Zydus Cadila receives U.S.FDA approval for leukaemia injection
Drug Approval | November 18, 2021

Zydus Cadila receives U.S.FDA approval for leukaemia injection

Nelarabine is in a class of medications called antimetabolites


Pfizer seeks EUA from U.S. FDA for Covid-19 drug
Biotech | November 17, 2021

Pfizer seeks EUA from U.S. FDA for Covid-19 drug

If approved or authorized, Paxlovid would be the first oral antiviral of its kind, to combat SARS-CoV-2


U.S FDA authorises EaseVRx, immersive virtual reality for pain relief
Drug Approval | November 17, 2021

U.S FDA authorises EaseVRx, immersive virtual reality for pain relief

EaseVRx employs the principles of cognitive behavioural therapy and other behavioural therapy techniques for the reduction of pain and pain interference


Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay
Biotech | November 12, 2021

Meridian Bioscience receives U.S. FDA Emergency Use Authorization for Revogene SARS-CoV-2 molecular assay

The company expects to begin shipping this product before the end of its fiscal first quarter, ending December 31, 2021


U.S. FDA approves ANI’s purified cortrophin gel
Biotech | November 03, 2021

U.S. FDA approves ANI’s purified cortrophin gel

Cortrophin gel is purified corticotropin (ACTH), an important treatment option for patients struggling with certain chronic autoimmune disorders. It acquired the NDA for cortrophin gel from Merck & Co. in 2016