News about Regulation

FDA Lifts Partial Clinical Hold on Vanda's Tradipitant for Motion Sickness

The lift allows Vanda to extend clinical studies of tradipitant in motion sickness. Meanwhile, the review of the fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track.

Regulation | 05/12/2025 | By Dineshwori |  391

FDA Approves Expanded Use of Eli Lilly's Jaypirca in Relapsed or Refractory CLL/SLL

Eli Lilly’s Jaypirca (pirtobrutinib) is the only medicine in CLL or SLL that has been prospectively studied in a randomised trial of patients previously treated with a covalent BTK inhibitor.

Regulation | 04/12/2025 | By Dineshwori |  208

NPPA Fixes Retail Prices for 11 Drug Formulations Under DPCO 2013

The National Pharmaceutical Pricing Authority (NPPA) has issued a fresh notification fixing retail prices for multiple essential drug formulations—including antihypertensives, antibiotics, antidiabetics, and paediatric syrups—under the Drugs (Prices Control) Order, 2013. The revised prices apply to approved manufacturers and exclude GST.

Regulation | 02/12/2025 | By Dineshwori |  207

Biocomposites Gains Expanded Approval in India for STIMULAN Rapid Cure

According to Biocomposites, India is the first country in the world to approve STIMULAN Rapid Cure to be mixed with antifungals.

Regulation | 01/12/2025 | By Dineshwori |  192

Dr. Reddy's Wins European Approval for Denosumab Biosimilar

Dr. Reddy’s Laboratories has received approval from the European Commission for its denosumab biosimilar, used in the treatment of osteoporosis and cancer-related bone conditions.

Regulation | 25/11/2025 | By Darshana |  192

Ocuvex Resubmits CRL to FDA for PDP-716 NDA, SPARC Reveals

Sun Pharma Advanced Research Company (SPARC) announced that Ocuvex Therapeutics has resubmitted a Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of PDP-716.

Regulation | 20/11/2025 | By Dineshwori |  306

Biocon Pharma Receives US FDA Nod for Tofacitinib Extended-Release Tablets

Biocon Pharma has received approval from the US Food and Drug Administration (US FDA) for its ANDA for tofacitinib extended-release tablets, securing final approval for the 11 mg strength and tentative approval for the 22 mg strength.

Regulation | 19/11/2025 | By Dineshwori |  275

Lilly India Receives CDSCO Approval for Donanemab to Treat Early Alzheimer's Disease

Eli Lilly and Company (India) Pvt. Ltd. has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) for donanemab, a treatment for adults in the early symptomatic stages of Alzheimer’s disease.

Regulation | 18/11/2025 | By Darshana |  369

EMA Enhances Scientific Advice Process for Medicines Targeting Public Health Threats

Under the new system, medicine developers can receive joint scientific advice from EMA and national clinical and ethics experts. This coordinated approach aligns trial and regulatory requirements early, helping accelerate trial approvals and access to critical medicines.

Regulation | 18/11/2025 | By Dineshwori |  294

Zydus Lifesciences Secures US FDA Approval for Leuprolide Acetate Injection

Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) for its generic version of Leuprolide Acetate injection, in a 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial format.

Regulation | 17/11/2025 | By Darshana |  264