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News about Regulation
In recent statements, the USA government announced plans to impose a 100 per cent tariff on branded pharmaceutical products from firms that have not established USA-based manufacturing, unless construction of such facilities has already begun.
Regulation | 29/09/2025 | By Darshana | 215
Biolinq Secures FDA De Novo Classification for Wearable Glucose Sensor
San Diego-based health tech startup Biolinq Incorporated has announced that the US Food and Drug Administration (FDA) has granted De Novo Classification for its lead product, Biolinq Shine, a fully autonomous, needle-free glucose sensor.
Regulation | 29/09/2025 | By Dineshwori | 434
GSK to submit label update for Wellcovorin at US FDA's request
GSK will file an sNDA with the US FDA to update Wellcovorin’s label to include Cerebral Folate Deficiency, following the agency’s request under its initiative to repurpose older drugs for chronic conditions.
Regulation | 24/09/2025 | By Dineshwori | 277
Dr. Reddy's Receives Positive CHMP Opinion from European Medicines Agency for Denosumab
Dr. Reddy’s Laboratories has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AVT03, a proposed biosimilar to Prolia and Xgeva, moving it closer to potential marketing authorisation in the European Economic Area (EEA).
Regulation | 24/09/2025 | By Dineshwori | 239
US FDA Grants Fast Track Designation to AAV Gene Therapy by Sanofi
The US FDA has granted fast track designation to Sanofi’s SAR446268, an AAV gene therapy for juvenile and adult-onset myotonic dystrophy type 1 (DM1).
Regulation | 23/09/2025 | By Dineshwori | 328
USFDA Completes Inspection of Indoco API Plant in Patalganga with Zero Observations
The inspection of Indoco’s API manufacturing facility at Patalganga by the US FDA concluded with zero form 483 observations.
Regulation | 22/09/2025 | By Dineshwori | 243
FDA Approves Subcutaneous Version of Keytruda for Solid Tumours
The U.S. Food and Drug Administration (FDA) has granted approval for a new subcutaneous formulation of Merck’s cancer immunotherapy Keytruda, now marketed as Keytruda Qlex.<br />
Regulation | 22/09/2025 | By Darshana | 236
Sanofi and Regeneron's Dupixent Receives Positive CHMP Opinion
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab), jointly developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents in the EU.
Regulation | 22/09/2025 | By Dineshwori | 448
PMO Steps In to Support Pharma MSMEs Facing Regulatory-Driven Crisis
The Prime Minister’s Office (PMO) has directed the Ministry of Micro, Small & Medium Enterprises to take urgent action after pharma MSMEs sounded an alarm over regulatory pressures affecting quality control compliance.
Regulation | 19/09/2025 | By Darshana | 298
NPPA Extends Price Cap on Orthopaedic Knee Implants Until November 15, 2025
The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price on orthopaedic knee implants for knee replacement systems by two months, pushing the deadline to 15 November 2025. The ceiling price, originally imposed in August 2017 in public interest, had been extended periodically, most recently up to 15 September 2025.
Regulation | 18/09/2025 | By Darshana | 2808
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