News about Regulation

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 |  107

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 |  107

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 |  130

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 |  120

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 |  244

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 |  143

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 |  176

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 |  192

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 |  148

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 |  110