News about Regulation

Gilead Sciences Wins FDA Accelerated Approval for First HDV Treatment Hepcludex

Gilead Sciences receives Food and Drug Administration (FDA) accelerated approval for Hepcludex, the first and only approved treatment for chronic Hepatitis Delta Virus (HDV), addressing a major unmet need in severe viral hepatitis care.

Regulation | 26/05/2026 | By News Bureau

Lupin Secures China Approval for Oseltamivir Phosphate Oral Suspension

Lupin receives approval in China for Oseltamivir Phosphate Oral Suspension 6 mg/mL, expanding access to influenza treatment, particularly for pediatric patients.

Regulation | 25/05/2026 | By News Bureau

India Brings Pregabalin under Schedule H1 to Curb Misuse and Strengthen Drug Regulation

Union Health Ministry has brought Pregabalin under Schedule H1 to strengthen prescription monitoring, regulate supply chains, and prevent misuse and unauthorised access to the widely used neurological medicine.

Regulation | 25/05/2026 | By News Bureau |  118

EMA Recommends Approval of Jascayd for IPF and Progressive Pulmonary Fibrosis

Jascayd receives positive CHMP recommendation for approval in Europe to treat Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF), addressing major unmet needs in severe and life-threatening lung diseases.

Regulation | 25/05/2026 | By News Bureau |  129

Camizestrant Plus CDK4/6 Inhibitor Recommended for EU Approval in Advanced ER-Positive Breast Cancer

Camizestrant plus a CDK4/6 inhibitor receives CHMP recommendation for EU approval in first-line advanced ER-positive breast cancer, supported by phase 3 SERENA-6 trial results showing a 56 percent reduction in disease progression or death.

Regulation | 25/05/2026 | By News Bureau

Alembic Pharmaceuticals Receives US FDA Final Approval for Levothyroxine Sodium Tablets

Alembic Pharmaceuticals receives final US Food and Drug Administration (FDA) approval for multiple strengths of Levothyroxine Sodium Tablets USP, expanding its portfolio of generic therapies for thyroid disorder management.

Regulation | 22/05/2026 | By News Bureau

MaaT Pharma Updates Marketing Authorisation Application for MaaT013 in Acute GvHD Treatment

MaaT Pharma reports a negative trend opinion from the EMA’s CHMP for the marketing authorisation application of MaaT013 in acute Graft-Versus-Host Disease (aGVHD), with plans to seek re-examination following the formal June CHMP vote.

Regulation | 21/05/2026 | By News Bureau |  217

Bayer Wins US FDA Priority Review for Asundexian Stroke Prevention Therapy

Bayer receives US Food and Drug Administration Priority Review (PR) for asundexian to reduce recurrent stroke risk after non-cardioembolic ischemic stroke or transient ischemic attack, supported by positive phase 3 OCEANIC-STROKE trial results.

Regulation | 20/05/2026 | By News Bureau

AstraZeneca Wins US Approval for Baxfendy, First Aldosterone Synthase Inhibitor for Hypertension

AstraZeneca receives US approval for Baxfendy, the first Aldosterone Synthase Inhibitor (ASI) for adults with hypertension, supported by phase 3 BaxHTN trial results showing significant reductions in systolic blood pressure.

Regulation | 20/05/2026 | By News Bureau

Lupin Gets US FDA Tentative Approval for Revefenacin Inhalation Solution

Lupin receives tentative US Food and Drug Administration (FDA) approval for Revefenacin Inhalation Solution, a generic version of Yupelri for maintenance treatment of Chronic
Obstructive Pulmonary Disease (COPD).<br />

Regulation | 20/05/2026 | By News Bureau