News about Regulation

FDA Approves Talazoparib with Enzalutamide for Prostate Cancer

The US FDA has approved talazoparib with enzalutamide for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer with HRR gene mutations.

Regulation | 03/11/2026 | By News Bureau

US FDA Approves First Plasmid DNA-based Immunotherapy

The US FDA has approved the first plasmid DNA-based immunotherapy for adults with recurrent respiratory papillomatosis, targeting the disease at its source.

Regulation | 02/11/2026 | By News Bureau

US FDA Approves NRx Pharmaceuticals' Preservative-Free Ketamine

NRx Pharmaceuticals has received the US FDA approval for preservative-free ketamine ahead of the agency’s November 10 goal date.

Regulation | 02/11/2026 | By News Bureau

WHO Publishes Target Profiles for Long-Acting Injectable TB Regimens

WHO publishes target regimen profiles to guide the development of long-acting injectable medicines for tuberculosis prevention and treatment.

Regulation | 30/10/2026 | By News Bureau

US FDA Approves Sun Pharma's ILUMYA for Psoriatic Arthritis

The US FDA has approved Sun Pharma’s ILUMYA in the US for adults with active psoriatic arthritis, expanding its use beyond plaque psoriasis.

Regulation | 30/10/2026 | By News Bureau

NPPA Cuts Prices of 543 Anti-Cancer Formulations by 90 Percent

NPPA has released price of 543 anti-cancer formulations under TMR with price cut upto over 90 percent, high priced drugs stay intact.

Regulation | 28/10/2026 | By News Bureau |  110

Alembic Pharma Gets US FDA Approval for Valganciclovir

Alembic Pharmaceuticals has received US FDA final approval for Valganciclovir Oral Solution 50 mg/mL, a generic equivalent of Valcyte by CHEPLAPHARM.

Regulation | 28/10/2026 | By News Bureau

EU Approves Enhertu for HER2-Positive Early Breast Cancer

The EU has approved Enhertu as adjuvant treatment for HER2-positive early breast cancer with residual disease, reducing recurrence or death risk by 53 percent vs. T-DM1.

Regulation | 28/10/2026 | By News Bureau

AMA and EMA Issue Joint Guidance on Ebola Vaccine Development

AMA and EMA have issued joint guidance on Ebola vaccine development, outlining clinical trial requirements to accelerate Bundibugyo virus vaccine development.

Regulation | 27/10/2026 | By News Bureau

UK MHRA Approves New Oral Treatment for Plaque Psoriasis

The UK MHRA has approved a new oral treatment for moderate to severe plaque psoriasis, offering an additional therapeutic option for patients in the UK.

Regulation | 26/10/2026 | By News Bureau