article thumbnail

Nedisertib by Merck for Neuroendocrine Tumors: Likelihood of Approval

Pharmaceutical Technology

It discovers, develops and manufactures prescription drugs to treat cancer, multiple sclerosis and infertility; and develops liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, pigments for coatings, and high-tech materials.

article thumbnail

Nedisertib by Merck for Head And Neck Cancer Squamous Cell Carcinoma: Likelihood of Approval

Pharmaceutical Technology

It discovers, develops and manufactures prescription drugs to treat cancer, multiple sclerosis and infertility; and develops liquid crystal mixtures, organic light-emitting diode (OLED) materials, cosmetic active ingredients, pigments for coatings, and high-tech materials.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Eli Lilly’s Olumiant Wins FDA Approval as First Systemic Treatment for Alopecia Areata

XTalks

Treatments for AA have been limited and largely cosmetic, such as the use of wigs and false eyelashes, or corticosteroid injections in the scalp. It blocks the activity of JAK1 and JAK2 to interfere with the JAK-STAT signaling pathway to dampen the production of inflammatory cytokines through the modulation of gene expression.

article thumbnail

Biologic Therapeutics Development, Part 2: Regulatory Pathways and Pharmacometric Analysis

Camargo

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act. Product Type-Specific Analysis.

article thumbnail

Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025

FDA Law Blog

This letter, dated March 21, 2025, cites Taihos false or misleading representations about the benefits of the drug, which is considered misbranding under the Federal Food, Drug, and Cosmetic Act. Join us as we break down what went wrong this time.

article thumbnail

FDA’s Issues Draft Guidance on Accelerated Approval: A Substantial Evidentiary and Procedural Overhaul to this High-Profile Pathway

FDA Law Blog

Since that time, it was formalized in FDA regulations (21 CFR 314 Subpart H) in 1992, codified in the Food, Drug, & Cosmetic Act by FDAMA (21 USC 356(c)) in 1997, revised by FDASIA in 2012, and described in guidance, most importantly, in the 2014 Expedited Programs for Serious Conditions Drugs and Biologics (2014 Guidance).

article thumbnail

Top 20 Best-Selling Neurology Drugs to Watch in 2024

XTalks

Why it sold so well: Zolgensma is a gene therapy classified as personalized or precision medicine, as it is designed to address specific issues arising from an individual’s unique genetic code. In 2020, Novartis Gene Therapies launched an innovative early access program for Zolgensma, designed to facilitate prompt patient access.