News about Regulation

NPPA to Cut Prices of 137 Anti-Cancer Drugs by Up to 70 Percent

NPPA has rationalised trade margins on 137 non-scheduled anti-cancer drugs, with MRPs expected to fall by up to 70 percent to improve affordability and access.

Regulation | 19/10/2026 | By News Bureau |  101

EU Recommends Ionis Pharma's TRYNGOLZA for CHMP Approval

Ionis Pharma's TRYNGOLZA has received CHMP recommendation for EU approval to treat severe hypertriglyceridemia, potentially becoming the first RNA-targeted therapy.

Regulation | 17/10/2026 | By News Bureau

US FDA Approves Roche's Enspryng for Thyroid Eye Disease

The US FDA has approved Roche’s Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED).

Regulation | 17/10/2026 | By News Bureau

US FDA Approves First Treatment for BCG-Unresponsive Bladder Cancer

The US FDA has expanded approval of Anktiva, offering a new treatment option for certain patients with BCG-unresponsive bladder cancer.

Regulation | 16/10/2026 | By News Bureau

UK MHRA Approves Onswik Insulin for Adults With Type 2 Diabetes

The UK MHRA has authorised Onswik (insulin efsitora alfa), a once-weekly insulin treatment for adults with Type 2 Diabetes, potentially reducing injections to 52 a year.

Regulation | 15/10/2026 | By News Bureau

US FDA Accepts Tabelecleucel BLA Resubmission for EBV-PTLD

The US FDA has accepted Pierre Fabre’s tabelecleucel BLA resubmission for EBV-positive PTLD, with a target decision date of March 31, 2027.

Regulation | 15/10/2026 | By News Bureau

FYB206 Becomes First Keytruda Biosimilar to Get US FDA Review

The US FDA has accepted FYB206’s Biologics License Application (BLA) for review, marking the first publicly announced Keytruda biosimilar filing acceptance.

Regulation | 13/10/2026 | By News Bureau

Roche's Tecentriq Wins US FDA Approval for Stage 3 Colon Cancer

The US FDA has approved Roche’s Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage 3 colon cancer.

Regulation | 13/10/2026 | By News Bureau

Teva Wins US FDA Approval for Monthly Olanzapine Injection

Teva has announced US FDA approval of WELTRUZA for ER injectable suspension, as the first and only once-monthly subcutaneous injectable polanzapine for adults.

Regulation | 12/10/2026 | By News Bureau

EMA Validates Hengrui Pharma's Fuzuloparib MAA

Hengrui Pharma has announced EMA validation of MAA for Wevdury (fuzuloparib) in combination with abiraterone for metastatic castration-resistant prostate cancer.

Regulation | 12/10/2026 | By News Bureau |  110