News about Regulation

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

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

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

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

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

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 |  187

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

Novartis Secures European Commission Approval for Itvisma in SMA

The European Commission (EC) has approved Novartis' Itvisma, the first gene replacement therapy in the European Union (EU) for a broad population with spinal muscular atrophy (SMA), including children, adolescents, and adults.

Regulation | 03/07/2026 | By News Bureau

Lupin Secures EMA Approval for Expanded NaMuscla Pediatric Use

Lupin has received EMA approval to expand the pediatric indication of NaMuscla, including two new capsule strengths of 62 mg and 83 mg.

Regulation | 03/07/2026 | By News Bureau |  334