Targeted Oncology5h
FDA Grants 225Ac-SSO110 Orphan Drug Status in SCLC
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
Zacks.com on MSN7h
Insmed's NDA for Lung Disease Drug Gets FDA's Priority Review
Insmed 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 ...
FDA grants priority review for potential bronchiectasis treatment
BRIDGEWATER, N.J. - Insmed Incorporated (NASDAQ:INSM), a biopharmaceutical company with a market capitalization of $14.57 ...
U.S. FDA approves Supernus' drug-device combination for Parkinson's disease
The U.S. Food and Drug Administration has approved Supernus Pharmaceuticals' drug-device combination to treat ...
Targeted Oncology1d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
BioSpace7d
FDA Approves Vertex’s Journavx as First New Pain Drug in Decades
The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum ...
MedPage Today3d
FDA OKs New Wearable Treatment for Parkinson's Disease
The FDA approved an apomorphine hydrochloride infusion device (Onapgo) to treat motor fluctuations in adults with advanced ...
Magdalena Biosciences, a Joint Venture Between Jaguar Health and Filament Health, to Present February 10th at BIO CEO & Investor Conference
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 ...
JD Supra3d
End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...
COUR Pharmaceuticals Secures FDA Clearance of IND Application for CNP-103 in Type 1 Diabetes
The Phase 1b/2a study will assess the safety of CNP-103 in adults (aged 18-35) and pediatrics (aged 12-17) who have Stage III or newly diagnosed (within the last 6 months) T1D as well as C-peptide ...