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Latest From IntraBio Inc.

US FDA September User Fee Calendar Slims Down, Still Boasts More Than Five Novel Agents

New therapies in the wings include two candidates for Niemman-Pick disease type C, a first-in-class antipsychotic, a targeted oncology therapy under Real-Time Oncology Review, and a new drug for gastroparesis.

US FDA Performance Tracker Drug Review

Deal Watch: Lilly Turns To Oblique For Antibody Discovery

Plus deals involving Lilly/Oblique, Rafael Holdings/Cyclo, ADCendo/Multitude, Ocuvex/Visiox and more.

Deal Watch Business Strategies

10 Approvals To Watch Out For In Q3

After a quiet July, August and September are shaping up to be busy on the approvals front. Already this month, the US FDA has approved Adaptimmune’s Teclera for synovial sarcoma, Phathom’s Voquezna for gastro-esophageal reflux disease and Servier’s Voranigo for gliomas. Here, Scrip takes a look at ten other approvals for novel products in the offing for the third quarter.

Approvals Companies

New US FDA Genetic Metabolic Adcomm Needs More Candidates

Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.

Advisory Committees Rare Diseases
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