News about Regulation

Fresenius Wins US FDA and EMA Review Acceptance for Vedolizumab Biosimilar

Fresenius has secured US Food and Drug Administration (FDA) and European Medicines Agency (EMA) review acceptance for its vedolizumab biosimilar, targeting Ulcerative Colitis (UC) and Crohn's Disease (CD) in adults.

Regulation | 03/08/2026 | By News Bureau

India to Build Future-Ready Drug Regulatory Framework: J P Nadda

India will build a future-ready drug regulatory framework, with the Central Drugs Standard Control Organisation (CDSCO) set to launch an end-to-end digital regulatory platform within 18 months.

Regulation | 01/08/2026 | By News Bureau

EU Approves Datroway for First-Line Metastatic TNBC

The European Union (EU) has approved AstraZeneca and Daiichi Sankyo's Datroway for first-line metastatic Triple Negative Breast Cancer (TNBC), backed by positive phase 3 survival and PFS results.

Regulation | 01/08/2026 | By News Bureau

Viatris Wins US FDA Approval for Once-Weekly Gwyn Lo Contraceptive Patch

Viatris has received US Food and Drug Administration (FDA) approval for Gwyn Lo, a once-weekly low-dose estrogen contraceptive patch, expanding women's health treatment options.

Regulation | 30/07/2026 | By News Bureau

EU Approves Pfizer-BioNTech XFG-Adapted COVID-19 Vaccine

The European Commission (EC) has approved Pfizer-BioNTech's XFG-adapted COVID-19 vaccine, with more than 5 billion vaccine doses distributed worldwide.

Regulation | 30/07/2026 | By News Bureau

Alembic Wins US FDA Approval for Prucalopride Tablets

Alembic Pharmaceuticals has received US Food and Drug Administration (FDA) approval for generic Prucalopride Tablets, equivalent to Takeda's Motegrity, for Chronic Idiopathic Constipation (CIC).

Regulation | 29/07/2026 | By News Bureau

Cipla Wins US FDA Approval for Generic Advair Diskus

Cipla has received US Food and Drug Administration (FDA) approval for its generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all 3 strengths.

Regulation | 29/07/2026 | By News Bureau

Novartis Wins Health Canada Approval for RHAPSIDO in CSU

Novartis has received Health Canada approval for RHAPSIDO (remibrutinib), a new oral treatment for adults with Chronic Spontaneous Urticari (CSU).

Regulation | 29/07/2026 | By News Bureau

Biocon Receives Health Canada Approval for Yesintek Autoinjector Pen

Biocon has received Health Canada approval for the Yesintek autoinjector pen to treat plaque psoriasis, psoriatic arthritis, Crohn's Disease (CD) and Ulcerative Colitis (UC).

Regulation | 29/07/2026 | By News Bureau

NUZOLVENCE Wins Thai FDA Approval for Gonorrhea

Thailand's Food and Drug Administration (FDA) has approved NUZOLVENCE (zoliflodacin) for gonorrhoea, becoming the second country after the US to authorise the new antibiotic.

Regulation | 28/07/2026 | By News Bureau