First-in-human global studies initiated for ZW191, an antibody-drug conjugate (ADC) engineered to target folate receptor-⍺ (FR⍺) and ZW171, a ...

Tiziana Life Sciences (TLSA) announced the submission of its Investigational New Drug, IND, application to the U.S. Food and Drug ...

The FDA is expected to decide on treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine.

2025 in – Submission of Investigational New Drug Application (IND) to US FDA expected in 2025 – NEW YORK, Feb. 04, 2025 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage ...

KalVista Pharmaceuticals, Inc. today announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of ...

Q4 2024 Earnings Call Transcript March 5, 2025 Zymeworks Inc. misses on earnings expectations. Reported EPS is $-0.31 EPS, ...

The centralised procedure aims to reduce repeated local reviews of a study application. For investigational new drug (IND) studies, submission can be done via the JIRB or CIRB. The JIRB has been ...

today announced that the Company has completed its rolling New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational and potential first-in-class ...

permit may be required and/or import may be prohibited unless there is an active Investigational New Drug (IND) application. If the product has been coated, there may be issues with countries ...

ABI-201 is undergoing IND-enabling studies and uses the same capsid as the firm's clinical-stage gene therapy candidate for wet AMD.