FDA nod to Johnson & Johnson’s oral psoriasis therapy 'ICOTYDE'

New targeted pill offers hope for adults and teens with moderate-to-severe plaque psoriasis

Roche breaks lab barriers as FDA clears mass spec tests for wider use

The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio

Sun Pharma scores FDA review for ILUMYA in psoriatic arthritis

ILUMYA has already earned FDA approvals for scalp and nail plaque psoriasis in April 2024 and December 2025

Novartis’ Cosentyx gains FDA nod for pediatric hidradenitis suppurativa patients

The approval of Cosentyx represents an important advancement for younger HS patients who have had limited treatment options

QIAGEN bags FDA nod for full GI testing on QIAstat-Dx Rise system

The approval means US laboratories can now run both respiratory and gastrointestinal panels on the high-throughput QIAstat-Dx Rise

Zydus receives USFDA approval for cevimeline hydrochloride capsules

Cevimeline Hydrochloride Capsules 30mg are indicated for the symptomatic treatment of dry mouth (xerostomia) associated with Sjögren’s syndrome.

Caplin Steriles gets USFDA approval for potassium phosphates injection

APL Healthcare’s Unit-IV classified as VAI by the USFDA

This inspection is now closed

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers

FDA nod to LifeVac De Novo, paving for next-generation anti-choking device

The FDA classified LifeVac as a Class II medical device