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Replicate Bioscience has been awarded a USD 3 million grant from the Gates Foundation to advance the development of self-replicating RNA-based tuberculosis vaccines, expanding its efforts to combat major infectious diseases including TB, HIV, malaria and rabies.
Quality / GMP | 20/06/2026 | By News Bureau | 111
Chugai Files Regulatory Application in Japan for IgA Nephropathy Drug Sparsentan
Chugai Pharmaceutical has applied for regulatory approval in Japan for sparsentan, a dual-action oral therapy for IgA nephropathy. Clinical studies showed significant reductions in proteinuria and potential benefits in preserving kidney function, offering hope for patients with limited treatment options.
Quality / GMP | 20/06/2026 | By News Bureau | 119
Allergan Aesthetics Secures FDA Approval for Skinvive by Juvederm to Treat Neck Wrinkles
Allergan Aesthetics, an AbbVie company, has received US FDA approval for Skinvive by Juvéderm to reduce neck wrinkles and improve overall neck appearance.
Quality / GMP | 18/06/2026 | By News Bureau
WuXi Biologics Secures 4th EMA GMP Certification for Suzhou Facility
WuXi Biologics’ Suzhou Biosafety Testing Center has received its 4th EMA GMP certification, supporting European Union (EU) Marketing Authorisation (MA) applications for 19 biologics from 13 stakeholders.
Quality / GMP | 18/06/2026 | By News Bureau
Alembic Pharma Receives US FDA Approval for Generic Tretinoin Cream
Alembic Pharmaceuticals has secured final USFDA approval for its generic Tretinoin Cream USP, 0.05 percent, used in the treatment of acne vulgaris, targeting a US market estimated at USD 76 million.
Quality / GMP | 16/06/2026 | By News Bureau | 109
Bayer Secures US FDA Approval for Ambelvist, a Low-Dose MRI Contrast Agent
Bayer’s Ambelvist (gadoquatrane) has received US FDA approval for contrast-enhanced MRI in adults and children, offering effective lesion visualization while reducing gadolinium exposure through a low-dose formulation.
Quality / GMP | 16/06/2026 | By News Bureau
AstraZeneca's Ultomiris Granted FDA Priority Review for Rare Kidney Disease IgAN
The US FDA has granted Priority Review to AstraZeneca’s supplemental application for Ultomiris in immunoglobulin A nephropathy, bringing the therapy closer to becoming the first C5 complement inhibitor approved for the rare kidney disease.
Quality / GMP | 16/06/2026 | By News Bureau | 106
Concord Biotech Successfully Completes ANVISA Inspection at Limbasi API Manufacturing Facility
Concord Biotech has successfully completed an ANVISA inspection at its Limbasi Active Pharmaceutical Ingredient (API) manufacturing facility, strengthening its regulatory standing and expansion into Brazil's pharmaceutical market.
Quality / GMP | 12/06/2026 | By News Bureau
Lupin Receives US FDA Approval for Interchangeable Biosimilar Ranibizumab, Ranluspec
Lupin has secured US FDA approval for Ranluspec (ranibizumab-hkdz), an interchangeable biosimilar to Lucentis, expanding its biosimilars portfolio and broadening access to treatments for retinal and vision-related disorders.
Quality / GMP | 05/06/2026 | By News Bureau | 108
Agilent Technologies has received FDA approval to expand the use of its PD-L1 IHC 22C3 pharmDx test on the Dako Omnis platform, broadening access to PD-L1 testing for four additional tumour types and supporting streamlined pathology laboratory operations.
Quality / GMP | 05/06/2026 | By News Bureau | 140
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