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Results For "Food-and-Drug-Administration"

1172 News Found

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP
Drug Approval | June 24, 2022

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.


Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant
Drug Approval | June 23, 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients


Merck presents positive results from phase 1/2 study evaluating V116
News | June 22, 2022

Merck presents positive results from phase 1/2 study evaluating V116

V116 designed to target serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019


Cadila Pharma launches formulation development lab
News | June 21, 2022

Cadila Pharma launches formulation development lab

The ground floor of the formulation development laboratory is focused on solid orals, the first floor on injections, and the second floor houses the analytical lab


Dr. Reddy's Lab launches sorafenib tablets in US
News | June 15, 2022

Dr. Reddy's Lab launches sorafenib tablets in US

Dr. Reddy's Sorafenib Tablets, USP, are available in 200 mg tablets in bottle count sizes of 120.


Eli Lilly gets FDA approval for alopecia drug
Drug Approval | June 15, 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head


Philips announces positive research results from its TOBA II BTK clinical trial
Clinical Trials | June 14, 2022

Philips announces positive research results from its TOBA II BTK clinical trial

First and only FDA-approved device of its kind demonstrates consistently high rates of target limb salvage and freedom from clinically-driven target lesion revascularization


FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer
Drug Approval | June 14, 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial


Marinus expands enrollment criteria to support recruitment in Phase 3 RAISE Trial in refractory status epilepticus
Clinical Trials | June 10, 2022

Marinus expands enrollment criteria to support recruitment in Phase 3 RAISE Trial in refractory status epilepticus

Marinus has broadened inclusion criteria in the RAISE trial to allow for enrollment of patients previously treated with IV anesthesia.


Sanofi Dupixent gets USFDA nod for atopic dermatitis
Drug Approval | June 10, 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood