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Results For "Food-and-Drug-Administration"

1018 News Found

Moderna and Merck announce an investigational individualized neoantigen therapy
Diagnostic Center | April 17, 2023

Moderna and Merck announce an investigational individualized neoantigen therapy

mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients


FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric
Drug Approval | April 14, 2023

FDA accepts application for Merck’s Keytruda plus chemotherapy as first-line treatment for metastatic gastric

Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression


Zydus receives final approval from USFDA for Tavaborole Topical Solution
Drug Approval | April 12, 2023

Zydus receives final approval from USFDA for Tavaborole Topical Solution

Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States


Zydus receives final approval from the USFDA for Azithromycin Tablets
Drug Approval | April 11, 2023

Zydus receives final approval from the USFDA for Azithromycin Tablets

Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States


Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug
Drug Approval | April 11, 2023

Shilpa Medicare receives USFDA approval for Psoriatic Arthritis Drug

Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.


Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Carbidopa and Levodopa Tablets

Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms


Zydus receives final approval from the USFDA for Acetazolamide Tablets
Drug Approval | April 07, 2023

Zydus receives final approval from the USFDA for Acetazolamide Tablets

Acetazolamide is used to treat glaucoma


FDA approves Merck’s Keytruda in combination with Padcev for treatment of metastatic urothelial cancer
Drug Approval | April 04, 2023

FDA approves Merck’s Keytruda in combination with Padcev for treatment of metastatic urothelial cancer

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients


Hutchmed completes rolling submission of NDA to USFDA for fruquintinib
Drug Approval | April 03, 2023

Hutchmed completes rolling submission of NDA to USFDA for fruquintinib

NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China


MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine
News | March 30, 2023

MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine

Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers