XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

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FDA Approval Gene Expression Cosmetics Trials 97

Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. Premarket Approval (PMA) process (CBER). Regulatory Considerations for Biologics. BLA process (CBER). NDA process (CBER).

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Development Production Immune Response Licensing 161

Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002.

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Filler Cosmetics Production Dermatology 40

FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). exclusively licensed U.S. and OPKO Ireland Ltd.

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

Filler 92

Filler FDA Approval Dermatology Production 92

Advarra

JULY 19, 2022

Also consider quality agreements for key vendors, such as contract development and manufacturing organizations (CDMO) and CROs. The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. For more information on form FDA 1572 refer to Frequently Asked Questions – Statement of Investigator (Form FDA 1572).

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Packaging Packaging Drugs Containment 52

XTalks

AUGUST 2, 2023

is a global pharmaceutical company, working across both developed and emerging markets. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities. Pfizer Inc. billion.

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Sales Manufacturing FDA Approval Life Science 98