News about Regulation

Otsuka Receives US FDA Approval for First-in-Class SIMTRIYO

The US Food and Drug Administration (FDA) has approved Otsuka's SIMTRIYO, the first Norepinephrine, Dopamine, Serotonin Reuptake Inhibitor (NDSRI) for treating ADHD in adults and children aged 6 years and older weighing at least 20 kg.

Regulation | 27/07/2026 | By News Bureau

EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab

If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the European Union (EU) in more than a decade for first-line HER2-positive metastatic breast cancer.

Regulation | 25/07/2026 | By News Bureau

CHMP Recommends AstraZeneca's Trixeo for EU Approval in Asthma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended EU approval of AstraZeneca's Trixeo for asthma maintenance, backed by positive phase 3 KALOS and LOGOS trial results.

Regulation | 25/07/2026 | By News Bureau

CHMP Recommends EU Approval of Roche's Susvimo

The Committee for Medicinal Products for Human Use (CHMP) has recommended EU approval of Roche's Susvimo, the first continuous delivery treatment offering an alternative to regular eye injections for wet Age-related Macular Degeneration (AMD).

Regulation | 25/07/2026 | By News Bureau

Jideytro Wins US Approval for ROS1-Positive NSCLC

Jideytro (zidesamtinib) has won US approval for previously treated ROS1-positive NSCLC, backed by ARROS-1 trial results showing durable responses.

Regulation | 24/07/2026 | By News Bureau

Udaiti Foundation Unveils Playbook to Advance Women's Participation in Pharma Manufacturing

The Udaiti Foundation has launched Gender-Smart Manufacturing: A Leadership Playbook for Building Inclusive Shopfloors, offering a practical roadmap to increase women's participation in production, engineering, maintenance and frontline supervision.

Regulation | 22/07/2026 | By News Bureau

India Approves Takeda's TAK-003 as First Dengue Vaccine

India approves Takeda's TAK-003 as its first dengue vaccine, offering long-term protection against dengue disease and hospitalisation amid rising dengue cases.

Regulation | 22/07/2026 | By News Bureau

Emcure Receives CDSCO Nod to Expand Poviztra's Use for MASH Indication

Emcure has received CDSCO approval to expand Poviztra's use for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), addressing a major unmet need in progressive liver disease treatment.

Regulation | 21/07/2026 | By News Bureau

EMA Accepts Bexsero Label Update for Meningitis B Booster

The European Medicines Agency (EMA) has accepted a label update for Bexsero that could enable a single booster dose to protect individuals aged 10 years and older previously vaccinated against Meningitis B.

Regulation | 21/07/2026 | By News Bureau

Roche's Gazyva Receives US FDA Priority Review for Membranous Nephropathy

The US Food and Drug Administration (FDA) has granted Priority Review to Roche's Gazyva for primary membranous nephropathy, supported by phase 3 MAJESTY trial results showing superior complete remission versus tacrolimus.

Regulation | 17/07/2026 | By News Bureau |  104