The FDA approved an apomorphine hydrochloride infusion device (Onapgo) to treat motor fluctuations in adults with advanced ...
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Insmed's promising drug pipeline includes Brensocatib and Arikayce. See why INSM stock is a strong pick with multi-billion ...
Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ...
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...
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Insmed's NDA for Lung Disease Drug Gets FDA's Priority ReviewInsmed Incorporated INSM announced that the FDA has accepted its new drug application (“NDA”) seeking approval of its reversible inhibitor of dipeptidyl peptidase 1 (DPP1), brensocatib, for treating ...
Celltrion launches ADC cancer drug trials in U.S. while planning additional INDs Celltrion accelerates its global drug ...
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