News about "Regulatory Approval "

US FDA and EMA Accept Cemdisiran Regulatory Submissions for Generalised Myasthenia Gravis

US FDA and EMA Accept Cemdisiran Regulatory Submissions for Generalised Myasthenia Gravis

The FDA and EMA have accepted regulatory submissions for cemdisiran to treat generalised Myasthenia Gravis (gMG). If approved, it could become the first siRNA therapy for gMG with convenient quarterly subcutaneous dosing.

Regulatory Approval | 25/06/2026 | By News Bureau 113

UK Accelerates Clinical Trials, Slashing Set-Up Time to Boost Patient Access

UK Accelerates Clinical Trials, Slashing Set-Up Time to Boost Patient Access

Government-backed reforms and Euro 137 million investment cut trial start times significantly, enabling faster access to innovative treatments through the National Health Service.

Regulatory Approval | 17/04/2026 | By News Bureau 108

NIH Scientists Discover Safer, Highly Potent Opioid with Potential for Pain and Addiction Treatment

NIH Scientists Discover Safer, Highly Potent Opioid with Potential for Pain and Addiction Treatment

A newly discovered opioid compound by NIH researchers shows strong pain relief without typical addiction risks, marking a potential breakthrough in safer pain management therapies.

Regulatory Approval | 06/04/2026 | By News Bureau 171

Glenmark Secures China's Approval For RYALTRIS

Glenmark Secures China's Approval For RYALTRIS

Glenmark Pharmaceuticals has received regulatory approval in China for RYALTRIS. Combining olopatadine hydrochloride and mometasone furoate, it offers dual-action relief from nasal symptoms, further strengthening Glenmark’s position as a global leader in respiratory innovation.

Regulatory Approval | 11/11/2025 | By Dineshwori 520

Azenta Receives Regulatory Approval for Clinical Long-Read WGS Test

Azenta Receives Regulatory Approval for Clinical Long-Read WGS Test

Performed within GENEWIZ from Azenta Life Sciences' CLIA-certified and CAP-accredited state-of-the-art clinical genomics laboratory, the test enables precise detection of a range of complex genomic alterations that are features of many rare diseases and undetectable by traditional approaches.

Regulatory Approval | 15/11/2024 | By Aishwarya 351


 

 

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