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Results For "ANDA"

2596 News Found

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension
Drug Approval | March 27, 2024

FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension

WINREVAIR is a breakthrough biologic for this rare, progressive disease


AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer
Clinical Trials | March 23, 2024

AstraZeneca’s FLAURA2 Phase III trial showed favourable trend in EGFR-mutated advanced lung cancer

Combination shows consistent benefit across prespecified post-progression outcomes


Dr. Reddy's and Pharmazz inks agreement to market Centhaquine for hypovolemic shock in India
Drug Approval | March 23, 2024

Dr. Reddy's and Pharmazz inks agreement to market Centhaquine for hypovolemic shock in India

Centhaquine is a resuscitative agent presently indicated for the treatment of hypovolemic shock by DGCI


Zydus receives tentative approval from USFDA for Letermovir Tablets
Drug Approval | March 23, 2024

Zydus receives tentative approval from USFDA for Letermovir Tablets

Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)


Bristol Myers Squibb completes acquisition of Karuna Therapeutics
News | March 21, 2024

Bristol Myers Squibb completes acquisition of Karuna Therapeutics

KarXT, Karuna’s lead asset, is a potential first-in-class treatment for Schizophrenia


Elegen launches Enfina DNA enhancement for rapid synthesis of highly complex DNA
Biotech | March 21, 2024

Elegen launches Enfina DNA enhancement for rapid synthesis of highly complex DNA

Elegen is the only DNA manufacturer delivering the unique combination of complexity, length and NGS-verified accuracy within days


Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray
Drug Approval | March 20, 2024

Aurobindo Pharma receives USFDA approval for Mometasone Furoate Monohydrate nasal spray

The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024


Aster’s India and GCC business separation nearing completion
Healthcare | March 20, 2024

Aster’s India and GCC business separation nearing completion

The plan essentially was to separate Aster’s India and GCC businesses to unlock long-term value


Carbogen Amcis (Shanghai) completed ANVISA Audit
Drug Approval | March 19, 2024

Carbogen Amcis (Shanghai) completed ANVISA Audit

A five-day inspection was concluded successfully with no critical and no major observations raised


Zydus receives USFDA approval for Finasteride and Tadalafil capsules
Drug Approval | March 18, 2024

Zydus receives USFDA approval for Finasteride and Tadalafil capsules

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