News about Quality / GMP

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 |  102

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 |  101

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

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 |  123

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

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 |  172

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

Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets

U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.

Quality / GMP | 30/03/2026 | By News Bureau |  105

Eli Lilly and Company's Ebglyss Shows Four-Year Durable Relief in Atopic Dermatitis Study

Long-term phase III data reveal sustained skin clearance and itch reduction with once-monthly dosing in eczema patients.

Quality / GMP | 30/03/2026 | By News Bureau |  106

Denali Therapeutics Wins FDA Approval for AVLAYAH in Hunter Syndrome

US FDA approves Denali Therapeutics’ AVLAYAH for Hunter syndrome (MPS II), the first new treatment in nearly 20 years and a novel biotherapeutic designed to cross the blood-brain barrier.

Quality / GMP | 26/03/2026 | By News Bureau