PharmaTher updates FDA new drug application for Ketamine
PharmaTher Holdings (CSE:PHRM) is on track to resubmit information to the U.S. Food and Drug Administration (FDA) by the end ...
Medscape7d
Introduction to the New Prescription Drug Labeling by the Food and Drug Administration
The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.
Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has ...
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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 ...
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on ...
manilatimes19h
IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Hong Kong Department of Health
SHANGHAI and NANJING, China and SAN JOSE, Calif., Feb. 14, 2025 /PRNewswire/ -- IASO Biotherapeutics ('IASO Bio'), a biopharmaceutical company focused on the discovery, development, manufacturing, and ...
Targeted Oncology7d
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 ...
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IASO Bio Announces Acceptance of New Drug Application for Equecabtagene Autoleucel (FUCASO) by the Singapore Health Sciences Authority (HSA)
has officially accepted the New Drug Application (NDA) for Equecabtagene Autoleucel. This treatment is indicated for patients with relapsed and/or refractory multiple myeloma (R/R MM) who have ...
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 ...
PharmaTher Provides Update on FDA New Drug Application for Ketamine
PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamineTORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- ...
Biohaven Ltd.: Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. Troriluzole demonstrated a 50-70% slowing of SCA disease progression ...