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Results For "approval"

2608 News Found

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’
Drug Approval | July 26, 2024

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials


Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution
Drug Approval | July 24, 2024

Gland Pharma receives USFDA’s tentative approval for Latanoprostene Bunod Ophthalmic Solution

The product is bioequivalent and therapeutically equivalent to the reference listed drug


Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH
Drug Approval | July 24, 2024

Shilpa Biologicals receives registration approval for Adalimumab from Morocco, MoH

Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL)


Zydus receives USFDA’s final approval for Valsartan Tablets
Drug Approval | July 24, 2024

Zydus receives USFDA’s final approval for Valsartan Tablets

The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India


Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP
Drug Approval | July 23, 2024

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension


Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Drug Approval | July 22, 2024

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well


Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection
Drug Approval | July 22, 2024

Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)


Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD
Drug Approval | July 19, 2024

Kwality Pharmaceuticals receives DIGIMED approval for generic, injectable and OSD

Kwality Pharma already has registration of 20 molecules from the units and 20 are under registration