FDA rejects Vanda’s jet lag drug in current form

Vanda strongly disputes the FDA’s reasoning

Caplin Point Labs acquires 10 ANDAs, targets $473M US market

The portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025

Vanda Pharmaceuticals seeks FDA nod for breakthrough psoriasis drug

Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients

Revvity launch new somatic cancer reference standards to to boost precision in oncology diagnostics

The new MimixTM GeniTM reference standards were developed from the extensively tested Genome-in-a-Bottle Consortium (GIAB) cell line

Caplin Steriles receives FDA approval for ANDA Nicardipine Hydrochloride in 0.9% Sodium Chloride injection

Nicardipine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable

VectorBuilder Redefines Plasmid Standards with miniVec

Conventional plasmids as a pharmaceutical material are not only suboptimal in safety and function, but exceedingly costly to produce, prohibitively

FDA supports new ANDA prioritization pilot to support US generic drugs

Infinitus launches MCP server to bring standardized AI interoperability to healthcare

New infrastructure makes it possible for healthcare organizations to integrate AI agents seamlessly into critical workflows like benefit verification and prior authorization

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025