News about Regulation

Tamil Nadu Chemists Announces Statewide Shutdown on May 20 Over E-Pharmacy Concerns

Tamil Nadu Chemists and Druggists Association has announced a statewide shutdown of retail pharmacy outlets on May 20 following a directive from All India Organisation of Chemists and Druggists, citing concerns over unregulated e-pharmacy operations and online medicine sales.

Regulation | 18/05/2026 | By News Bureau |  1141

UK MHRA Approves Vyjuvek for Treatment of Dystrophic Epidermolysis Bullosa Wounds

Medicines and Healthcare products Regulatory Agency has approved Vyjuvek for treating wounds in patients with dystrophic epidermolysis bullosa, including newborns.

Regulation | 18/05/2026 | By News Bureau |  119

Piramal Pharma Closes US FDA Inspection at Telangana Manufacturing Facility

Piramal Pharma has announced the successful closure of a US FDA inspection at its manufacturing facility in Digwal, Telangana, after receiving the Establishment Inspection Report (EIR) from the regulator, confirming the completion of the inspection process.

Regulation | 18/05/2026 | By News Bureau |  176

US FDA Approves Enhertu for New Early Breast Cancer Indications

Enhertu receives new US approvals for use before and after surgery in HER2-positive breast cancer, supported by positive DESTINY-Breast11 and DESTINY-Breast05 phase 3 trial results.

Regulation | 18/05/2026 | By News Bureau |  128

AstraZeneca Wins US FDA Approval for Fasenra in Hypereosinophilic Syndrome

AstraZeneca receives US Food and Drug Administration (FDA) approval for Fasenra to treat hypereosinophilic syndrome, supported by positive phase 3 NATRON trial results.

Regulation | 16/05/2026 | By News Bureau |  141

CuraTeQ Biologics Secures CDSCO Approval for Bevqolva

CuraTeQ Biologics receives CDSCO marketing authorisation for Bevqolva, strengthening its oncology biosimilars portfolio and expanding access to advanced cancer therapies.

Regulation | 16/05/2026 | By News Bureau |  346

Alembic Pharmaceuticals Gets US FDA Tentative Nod for Darolutamide Tablets

Alembic Pharmaceuticals receives tentative US Food and Drug Administration (FDA) approval for Darolutamide Tablets 300 mg, a generic equivalent to Nubeqa by Bayer.

Regulation | 15/05/2026 | By News Bureau

Chugai Pharmaceutical Files Japan Approval for Gazyva in Idiopathic Nephrotic Syndrome

Chugai Pharmaceutical files a regulatory application in Japan for Gazyva to treat Idiopathic Nephrotic Syndrome (INS), based on phase 3 INShore study results.

Regulation | 15/05/2026 | By News Bureau

US FDA Approves INQOVI Plus Venetoclax for AML

The US Food and Drug Administration (FDA) approves INQOVI with venetoclax as the first all-oral combination treatment for acute myeloid leukemia patients ineligible for intensive chemotherapy, supported by positive ASCERTAIN-V trial data.

Regulation | 14/05/2026 | By News Bureau |  146

Lupin Secures FDA Approval for Famotidine Injection USP

Lupin has received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Famotidine injection USP, 20 mg/2 mL (10 mg/mL), single-dose vials.

Regulation | 14/05/2026 | By News Bureau |  198