News about Regulation

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 |  379

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 |  161

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

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 |  133

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 |  136

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 |  132

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 |  117

US FDA Launches One-Day Inspections to Boost Oversight

The FDA launches one-day inspectional assessments to strengthen oversight, using shorter, targeted reviews to complement standard inspections.

Regulation | 08/05/2026 | By News Bureau