News about Regulation

US FDA Grants Priority Review to Genentech?s Enspryng for MOGAD

The US Food and Drug Administration (FDA) has granted priority review to Genentech’s Enspryng for MOGAD after phase 3 METEOROID data showed a 68 percent reduction in relapse risk.

Regulation | 11/09/2026 | By News Bureau

US FDA Grants Accelerated Approval to Sevabertinib for Advanced NSCLC

The US Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with HER2 (ERBB2) TKD activating mutations.

Regulation | 11/09/2026 | By News Bureau

CDSCO Signals Shift toward Smarter, Risk-based Regulation to Ease of Doing Business for Indian Pharma

The Central Drugs Standard Control Organisation (CDSCO) signals smarter, risk-based pharma regulation at iPHEX 2026, calling for proportionate enforcement, simpler compliance and clearer regulatory norms.

Regulation | 09/09/2026 | By News Bureau |  131

Indoco Remedies Receives Seven Form 483 Observations Following US FDA Inspection

Indoco Remedies’ Plant 2 (Sterile) facility in Goa received seven Form 483 observations following a USFDA inspection conducted from August 27 to September 4, 2026.

Regulation | 08/09/2026 | By News Bureau |  192

Maharashtra FDA Conducts 2,902 Inspections, Acts Against 880 Drug Licence Holders

Maharashtra FDA’s intensified inspections identified compliance gaps across pharmaceutical manufacturing, sales, blood centres and storage facilities.

Regulation | 08/09/2026 | By News Bureau |  117

Lupin Receives US FDA Approval for Modafinil Tablets, USP

Lupin receives US FDA approval for Modafinil Tablets USP, 100 mg and 200 mg, bioequivalent to Provigil for the US market.

Regulation | 07/09/2026 | By News Bureau

US FDA Approves ZANVASTRO as First Disease-Modifying Treatment for Alexander Disease

The US Food and Drug Administration (FDA) approves ZANVASTRO (zilganersen) as the first disease-modifying treatment for Alexander Disease (AxD) in pediatric and adult patients.

Regulation | 05/09/2026 | By News Bureau |  113

US FDA Approves ETCAMAH Plus CDK4/6 Inhibitor for Advanced HR-Positive Breast Cancer

US approves ETCAMAH (camizestrant) plus a CDK4/6 inhibitor for first-line advanced HR-positive breast cancer, reducing progression or death risk by 56 percent.

Regulation | 05/09/2026 | By News Bureau

Milestone's Etripamil Nasal Spray Wins China NMPA Approval for PSVT

Milestone Pharmaceuticals’ etripamil nasal spray receives China NMPA approval for PSVT, triggering a USD 2 million payment and expanding access in Greater China.

Regulation | 05/09/2026 | By News Bureau

US FDA Approves Treatment for Essential Thrombocythemia

The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia, with a recommended starting dose of 250 mcg.

Regulation | 02/09/2026 | By News Bureau