News about Regulation

India and Australia Sign CSIR-TKDL Pact to Protect Traditional Knowledge

CSIR and IP Australia have signed a Traditional Knowledge Digital Library (TKDL) access agreement at the India-Australia Summit to strengthen traditional knowledge protection.

Regulation | 13/07/2026 | By News Bureau |  121

Government Revises Drugs Rules to Regulate High Alcohol-Content Medicines

India has strengthened regulation of high alcohol-containing drug formulations by bringing products with over 12 percent v/v ethyl alcohol under Schedule H1 and ending their Schedule K exemption.

Regulation | 10/07/2026 | By News Bureau |  187

US FDA Approves Accord BioPharma's ENNUMO Pegfilgrastim Biosimilar

The US Food and Drug Administration (FDA) has approved Accord BioPharma’s ENNUMO (pegfilgrastim-pccg), expanding its US biosimilar portfolio and strengthening access to G-CSF therapies for cancer patients.

Regulation | 10/07/2026 | By News Bureau |  144

Merck Wins US FDA Breakthrough Therapy Designation Status for Enpatoran in Lupus

Merck has received US Food and Drug Administration (FDA) Breakthrough Therapy Designation (BTD) for enpatoran in lupus patients with active skin manifestations, advancing a potential first approved treatment for cutaneous lupus.

Regulation | 09/07/2026 | By News Bureau |  120

Jascayd (Nerandomilast) Wins UK MHRA Approval for Pulmonary Fibrosis Treatment

Nerandomilast (Jascayd) has been approved for adults with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF), expanding treatment options for these chronic lung diseases.

Regulation | 09/07/2026 | By News Bureau |  188

Government Notifies Navi Mumbai Airport as Port for Import of Drugs under Drugs Rules, 1945

The Government of India has notified Navi Mumbai Airport as a port for drug imports under the Drugs Rules, 1945, expanding notified entry points to 42 and strengthening pharmaceutical logistics.

Regulation | 08/07/2026 | By News Bureau

UK MHRA Approves Retifanlimab for Merkel Cell Skin Cancer

The UK MHRA has approved retifanlimab (ZYNYZ) for the treatment of advanced Merkel Cell Carcinoma (MCC), a rare and aggressive skin cancer with significant unmet medical need.

Regulation | 08/07/2026 | By Akanki |  146

AbbVie Wins EU Approval for TEPKINLY in Combination with Lenalidomide and Rituximab

The European Commission has approved AbbVie's TEPKINLY with lenalidomide and rituximab as the first bispecific, chemotherapy-free treatment for Relapsed or Refractory Follicular Lymphoma in the second-line setting.

Regulation | 07/07/2026 | By News Bureau |  118

Granules India Secures Sole First-to-File ANDA Status for Sodium Oxybate Extended-Release for Oral Suspension

Granules India secures Sole First-to-File ANDA status for Sodium Oxybate Extended-Release for Oral Suspension, strengthening its US complex generics portfolio.

Regulation | 06/07/2026 | By Akanki |  247

HUTCHMED Secures NMPA Approval for ORPATHYS in Gastric Cancer

HUTCHMED has received NMPA approval for ORPATHYS, the first selective MET inhibitor in China for patients with MET-amplified advanced gastric cancer or gastroesophageal junction adenocarcinoma.

Regulation | 04/07/2026 | By News Bureau |  148