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Results For "FDA"

1718 News Found

NATCO files generic Olaparib Tablets in USA
News | February 14, 2023

NATCO files generic Olaparib Tablets in USA

Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic, and prostate cancer


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


Lupin Q2 FY23 revenue up 3.9%; Profit down 71%
News | February 10, 2023

Lupin Q2 FY23 revenue up 3.9%; Profit down 71%

With the recent sales force expansion and new product launches, we expect to be back to above-market growth


Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData
News | February 06, 2023

Janssen and Eli Lilly collaboration to address lack of pediatric therapies could rescue mirikizumab program, says GlobalData

The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).


Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection
Drug Approval | February 02, 2023

Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection

The Tc 99m Mertiatide Injection is used in the diagnosis of congenital and acquired renal abnormalities


Sun Pharma Q3 FY23 Gross Sales up 13.1%; Net profit up 5.2%
News | February 01, 2023

Sun Pharma Q3 FY23 Gross Sales up 13.1%; Net profit up 5.2%

India formulation sales at Rs. 3,391.9 crore, up 7.1% over Q3 last year


Kokilaben Hospital launches Ortho Robot ‘Stryker Mako’
Medical Device | January 31, 2023

Kokilaben Hospital launches Ortho Robot ‘Stryker Mako’

The only robotic-arm assisted surgical device to conduct joint replacement with accuracy and better clinical outcomes


Alkem to launch novel antibiotic for MDR infections
News | January 31, 2023

Alkem to launch novel antibiotic for MDR infections

Zidavi is recommended by the Infectious Disease Society of America


ExeGi Pharma gets clearance of IND application for EXE-346 a Live biotherapeutic biologic drug
Drug Approval | January 30, 2023

ExeGi Pharma gets clearance of IND application for EXE-346 a Live biotherapeutic biologic drug

This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis


Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US
News | January 28, 2023

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US

The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA