News about Regulation

Ipca Labs Receives US FDA Form 483 with Three Observations after Tarapur Facility Inspection

The US Food and Drug Administration (US FDA) has completed an inspection of Ipca Laboratories' Active Pharmaceutical Ingredients (APIs) manufacturing plant in Tarapur, Palghar (Maharashtra).

Regulation | 06/12/2025 | By Dineshwori |  1037

Lupin Receives Tentative US FDA Nod for Siponimod Tablets, Generic to Novartis' Mayzent

Lupin has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Siponimod Tablets in strengths of 0.25 mg, 1 mg and 2 mg.

Regulation | 05/12/2025 | By Dineshwori |  669

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 |  470

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 |  289

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 |  291

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 |  289

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 |  245

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 |  600

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 |  367

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 |  608