Latest News for: new drug application
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ENHERTU® Supplemental New Drug Application Submitted in Japan as Adjuvant Therapy for Patients with HER2 Positive Early Breast Cancer (Daiichi Sankyo Co Ltd)
Public Technologies 27 Feb 2026
) Press Release ENHERTU®Supplemental New Drug Application Submitted in Japan as Adjuvant Therapy for Patients with HER2 Positive Early Breast Cancer ...
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Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% ...
Nasdaq Globe Newswire 25 Feb 2026
Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine Ophthalmic Solution 0.75% for the Treatment of Presbyopia ... .
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Hastings Tribune
25 Feb 2026
Opus Genetics Announces FDA Acceptance of Supplemental New Drug Application for Phentolamine
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FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia
PR Newswire 25 Feb 2026
Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for MR-141 (phentolamine ophthalmic solution 0.75%) for the treatment of presbyopia.
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Rutland Herald
23 Feb 2026
Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick ...
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Beren Therapeutics Announces FDA Acceptance of its New Drug Application for Adrabetadex in Infantile-Onset Niemann-Pick Disease Type C
Pharmiweb 23 Feb 2026
Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for adrabetadex, an investigational cyclodextrin therapy designed to increase intracellular cholesterol trafficking in Niemann-Pick disease type C (NPC).
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Hastings Tribune
21 Feb 2026
U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for
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U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release ...
Nasdaq Globe Newswire 20 Feb 2026
Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable ...
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The Galveston Daily News
20 Feb 2026
FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer
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FDA accepts New Drug Application for Roche’s giredestrant in ESR1-mutated, ER-positive advanced breast cancer
Nasdaq Globe Newswire 20 Feb 2026
RHHBY) announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an ...
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Medincell: U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults
Pharmiweb 20 Feb 2026
Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.
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FDA Accepts New Drug Application for Genentech’s Giredestrant in ESR1-Mutated, ER-Positive Advanced Breast Cancer (Genentech Inc)
Public Technologies 20 Feb 2026
Food and Drug Administration (FDA) has accepted the company's New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients ...
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Medincell: U.S. Food and Drug Administration (FDA) Accepts Teva’s New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults (Medincell SA)
Public Technologies 20 Feb 2026
Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for olanzapine extended-release injectable suspension (TEV-'749) for the treatment of schizophrenia in adults.
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The Joplin Globe
17 Feb 2026
U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Iberdomide in ...
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