Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

In May 2024, Zai Lab announced that the Centre for Drug Evaluation (CDE) accepted the sBLA with priority review designation for VYVGART Hytrulo for CIDP in China. The CDE granted the Breakthrough ...

The OBR (Office for Budget Responsibility) anticipates economic output in Britain to expand by 1.8% in 2026 and by 1.5% in ...

A new drug application (NDA) has been submitted to the FDA for sunvozertinib in pretreated EGFR exon 20–positive advanced non ...

Arcutis Biotherapeutics Inc ( (ARQT) ) has released its Q3 earnings. Here is a breakdown of the information Arcutis Biotherapeutics Inc ...

Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical ...

Topline results are expected in Q4 2025 and Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a US label extension in 2026, subject to positive data. Grünenthal announced ...

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced business updates and reported financial results for the ...

The Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for tapinarof cream, 1% in the treatment of atopic dermatitis in adults and ...

Organon (OGN) stock on watch as FDA delays a potential label expansion for its VTAMA cream, impacting 2025 EBITDA margin and ...

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) announced a remarkable achievement with $186.0 million in net revenue for ...