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News about Regulation
FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing
More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.
Regulation | 06/10/2025 | By Dineshwori | 102
Sitryx receives FDA clearance of IND application for SYX-5219 for the treatment of atopic dermatitis
Sitryx’s SYX-5219 is a first-in-class, oral, disease-modifying, anti-inflammatory therapy, targeting pyruvate kinase M2 (PKM2), a critical enzyme that regulates cell metabolism.
Regulation | 04/10/2025 | By Dineshwori | 152
CDSCO approves AstraZeneca's Trastuzumab Deruxtecan for More HER2-Positive Tumours
With this, Trastuzumab Deruxtecan becomes India’s first Antibody Drug Conjugate (ADC) approved for a tumour-agnostic indication.
Regulation | 04/10/2025 | By Dineshwori | 231
Rajasthan Bans Distribution of 19 Kaysons Pharma Medicines, Suspends Drug Controller
The Rajasthan government has ordered the suspension of distribution for 19 medicines marketed by Kaysons Pharma, citing serious concerns over drug safety. Concurrently, the state has suspended its Drug Controller, Rajaram Sharma, in connection with alleged irregularities in setting quality standards.
Regulation | 04/10/2025 | By Darshana | 141
CDSCO Clarifies Approval Process for Lyophilized Injection Combi-Packs
The drug regulator has specified when combi-packs of lyophilized injections with diluents will require fresh CDSCO approval and when licenses can be issued directly by State Licensing Authorities.
Regulation | 30/09/2025 | By Dineshwori | 179
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 | 139
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 | 274
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 | 127
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 | 107
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 | 183
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