Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU

These approvals represent a defining moment for people living with classical Hodgkin Lymphoma

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

Lilly expands access to Zepbound weight-loss drug with $299 monthly self-pay option

The expanded program allows patients to fill prescriptions either at a local pharmacy or through home delivery via LillyDirect

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 first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature

FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials

SEQSTER launches 1-Click DataLake, unlocking real-world health data from 150M+ patients

The company says those insights can power advanced analytics and real-world evidence (RWE), helping researchers improve trial design, study feasibility, and recruitment strategies