News about Regulation

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 |  270

FDA Advances Drug Repurposing to Address Unmet Medical Needs

US Food and Drug Administration (FDA) is advancing drug repurposing to accelerate treatments for chronic and rare diseases, addressing unmet medical needs with faster, cost-effective innovation.

Regulation | 13/05/2026 | By News Bureau |  402

Coya Therapeutics Wins FDA Fast Track for COYA 302 in Amyotrophic Lateral Sclerosis

Coya Therapeutics receives US Food and Drug Administration (FDA) Fast Track designation for COYA 302, an investigational biologic therapy for Amyotrophic Lateral Sclerosis (ALS).

Regulation | 13/05/2026 | By News Bureau |  194

Partner Therapeutics Wins FDA Approval for BIZENGRI in NRG1+ Cholangiocarcinoma

Partner Therapeutics receives US Food and Drug Administration (FDA) approval for BIZENGRI, the first targeted therapy for NRG1 fusion-positive cholangiocarcinoma, expanding use across NSCLC and pancreatic cancer.

Regulation | 12/05/2026 | By News Bureau |  126

Transpire Bio Secures FDA Filing Acceptance for Generic High-Strength Trelegy Ellipta ANDA

Transpire Bio receives US Food and Drug Administration (FDA) filing acceptance for its generic high-strength Trelegy Ellipta ANDA with Paragraph IV certification under the Hatch-Waxman Act.

Regulation | 12/05/2026 | By News Bureau |  203

Bristol Myers Squibb Secures EC Approval for Sotyktu in Psoriatic Arthritis

Bristol Myers Squibb receives European Commission (EC) approval for Sotyktu to treat active psoriatic arthritis in adults, marking the EU’s first approved TYK2 inhibitor for this indication.

Regulation | 12/05/2026 | By News Bureau |  218

LEQEMBI IQLIK Subcutaneous Dose Gets US FDA Priority Review for Early Alzheimer's Disease

LEQEMBI IQLIK subcutaneous dose review by US Food and Drug Administration (FDA) extended after major sBLA amendment for early Alzheimer’s disease, with no approvability concerns raised.

Regulation | 11/05/2026 | By News Bureau |  164

Biocon Secures Health Canada Nod for Micafungin Injection

Biocon Pharma receives Health Canada approval for Micafungin for Injection (50 mg, 100 mg), strengthening its biosimilars and generics portfolio.

Regulation | 11/05/2026 | By News Bureau

Pierre Fabre Pharmaceuticals Reports FDA Update on Tabelecleucel BLA

Pierre Fabre Pharmaceuticals aligns with US Food and Drug Administration (FDA) on BLA resubmission path for tabelecleucel, an allogeneic T-cell therapy for Epstein-Barr virus positive post-transplant lymphoproliferative disease.

Regulation | 08/05/2026 | By News Bureau

China's CDE Grants Priority Review to Bayer's FXIa Inhibitor

China’s Center for Drug Evaluation (CDE) grants Priority Review (PR) to Bayer’s FXIa inhibitor, highlighting its potential clinical value in reducing stroke risk.

Regulation | 08/05/2026 | By News Bureau |  140