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News about Regulation
Dr. Reddy's Laboratories Wins Health Canada Nod for Generic Semaglutide Injection
Dr. Reddy's Laboratories secures Health Canada approval for generic semaglutide injection, becoming the first to gain market authorisation in Canada ahead of the review timeline.
Regulation | 29/04/2026 | By News Bureau | 221
Johnson & Johnson Secures FDA Priority Review for Imaavy in Rare Blood Disorder
Johnson & Johnson moves closer to delivering a first-in-class treatment for Warm Autoimmune Haemolytic Anaemia with FDA Priority Review for Imaavy.
Regulation | 28/04/2026 | By News Bureau | 150
US FDA Approves CAPLYTA (lumateperone) sNDA for Schizophrenia Relapse Reduction
US Food and Drug Administration (FDA) approves CAPLYTA (lumateperone) sNDA for schizophrenia, showing a 63 percent reduction in relapse risk and 84 percent relapse-free patients over six months, with strong long-term safety and stability data.
Regulation | 28/04/2026 | By News Bureau | 290
National Institute for Health and Care Research launches a nationwide collaboration to accelerate Parkinson’s research, bringing together academia, NHS and charities to drive faster development of treatments and diagnostics.
Regulation | 27/04/2026 | By News Bureau | 126
IPC Signs MoUs with PMBI and NIPER Hajipur to Enhance Drug Quality and Safety
IPC signs MoUs with PMBI and NIPER Hajipur to enhance drug quality, pharmacovigilance, research, safety of biologics and emerging therapies, and patient safety across India, including Jan Aushadhi Kendras.
Regulation | 27/04/2026 | By News Bureau | 266
US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation
FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.
Regulation | 23/04/2026 | By News Bureau | 304
Supriya Lifescience Receives US FDA EIR with VAI Status for Lote Parshuram Facility
Supriya Lifescience receives US FDA EIR with VAI classification for its Lote Parshuram facility, closing the February 2026 audit inspection cycle.
Regulation | 23/04/2026 | By News Bureau | 296
NPPA directs companies to submit October 2023 pricing and turnover details for Gentamicin formulation as part of the updated price control framework under DPCO.
Regulation | 21/04/2026 | By News Bureau | 216
Lupin Subsidiary Settles US Antitrust Case with Humana
Lupin subsidiary Lupin Pharmaceuticals Inc has reached a USD 30 million settlement with Humana in a US antitrust case, resolving claims without any admission of liability.
Regulation | 17/04/2026 | By News Bureau | 188
Aurobindo Pharma Secures US FDA Approval for Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL
Aurobindo Pharma has secured USFDA approval for Glycerol Phenylbutyrate Oral Liquid 1.1 g/mL, to be manufactured at its Unit-III facility, with immediate launch planned to strengthen its specialty pharma portfolio.
Regulation | 17/04/2026 | By News Bureau | 255
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