News about Quality / GMP

Roche Secures CE Mark for Blood-Based Test to Monitor Multiple Sclerosis

Roche’s Elecsys NfL test receives CE approval, offering a simple blood-based method to detect neuroinflammation in multiple sclerosis, improving monitoring access and supporting more timely, personalised disease management.

Quality / GMP | 14/04/2026 | By News Bureau |  182

MHRA Approves Olezarsen (Tryngolza) for Familial Chylomicronemia Syndrome

MHRA approves olezarsen (tryngolza) for adults with Familial Chylomicronemia Syndrome with subcutaneous injection administration.

Quality / GMP | 13/04/2026 | By News Bureau |  177

Lynk Pharmaceuticals Secures NMPA NDA Acceptance for Zemprocitinib

Lynk Pharmaceuticals announces NMPA acceptance of Zemprocitinib NDA, backed by positive results from a phase-III randomised, double-blind, placebo-controlled clinical trial in China.

Quality / GMP | 11/04/2026 | By News Bureau |  154

DualityBio Secures China NMPA BLA Acceptance for Trastuzumab Pamirtecan in HER2+ Breast Cancer

DualityBio announces China NMPA acceptance of its BLA for trastuzumab pamirtecan, targeting unresectable or metastatic HER2-positive breast cancer in adult patients.

Quality / GMP | 10/04/2026 | By News Bureau |  186

BD Secures CE Mark for Liverty TIPS Stent Graft to Advance Portal Hypertension Treatment in Europe

The next-generation adjustable stent graft expands treatment options for cirrhosis-related complications, with pivotal ARCH trial data set for presentation at SIR 2026.

Quality / GMP | 09/04/2026 | By News Bureau |  220

Lupin Secures US FDA Approval for Dapagliflozin Tablets in US

Lupin secures US FDA approval for Dapagliflozin Tablets 5 mg and 10 mg in the US, bioequivalent to Farxiga.

Quality / GMP | 08/04/2026 | By News Bureau |  148

Alembic Pharmaceuticals Gains USFDA Approval for Dapagliflozin Tablets ANDA

Alembic Pharmaceuticals receives USFDA approval for Dapagliflozin Tablets ANDA, gaining eligibility for 180-day shared generic drug exclusivity and strengthening its diabetes portfolio.

Quality / GMP | 07/04/2026 | By News Bureau |  205

Alpha Cognition Secures US Patent for ALPHA-1062 in Traumatic Brain Injury Treatment

New patent protection through 2045 strengthens pipeline expansion beyond Alzheimer’s disease and targets unmet need in TBI therapeutics.
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Quality / GMP | 07/04/2026 | By News Bureau |  184

BioXcel Therapeutics Announces FDA Acceptance of Supplemental NDA for IGALMI

BioXcel Therapeutics receives FDA acceptance for supplemental NDA of IGALMI, targeting acute agitation in bipolar disorder and schizophrenia for potential at-home treatment use.

Quality / GMP | 02/04/2026 | By News Bureau |  291

Abbisko's Irpagratinib Secures EMA Orphan Drug Tag for Liver Cancer

European regulator grants rare disease designation to FGFR4 inhibitor, boosting its clinical development and commercial prospects in hepatocellular carcinoma.

Quality / GMP | 01/04/2026 | By News Bureau |  177