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Results For "United-States"

1202 News Found

Lupin receives USFDA approval for fluocinolone acetonide body oil
Drug Approval | August 09, 2023

Lupin receives USFDA approval for fluocinolone acetonide body oil

Fluocinolone Acetonide Oil (RLD Derma-Smoothe/FS®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2023)


Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma
Drug Approval | August 06, 2023

Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma

The inspection closed with zero observations and a classification of No Action Indicated


USFDA approves Merck’s ERVEBO for use in children 12 months of age and older
Drug Approval | August 05, 2023

USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease


Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations
Drug Approval | August 05, 2023

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023


Supriya Lifescience collaborates with Plasma Nutrition for protein technology
News | August 03, 2023

Supriya Lifescience collaborates with Plasma Nutrition for protein technology

The primary purpose of this collaboration is to bring the optimized protein into the Indian market


Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation
Drug Approval | August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.


Lupin receives approval from US FDA for Turqoz
Drug Approval | August 02, 2023

Lupin receives approval from US FDA for Turqoz

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)


Concord Biotech’s IPO to open on 4th August, 2023
News | August 01, 2023

Concord Biotech’s IPO to open on 4th August, 2023

The company through its IPO will fetch Rs 1475.26 crore - Rs 1550.59 crore at the lower and upper end of the price band.


Biogen to acquire Reata Pharmaceuticals
News | July 31, 2023

Biogen to acquire Reata Pharmaceuticals

Proposed acquisition represents meaningful step forward in Biogen’s strategy for sustainable growth


NATCO files generic Erdafitinib Tablets in USA
Drug Approval | July 26, 2023

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma