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Indoco Remedies Receives Seven Form 483 Observations Following US FDA Inspection
Indoco Remedies’ Plant 2 (Sterile) facility in Goa received seven Form 483 observations following a USFDA inspection conducted from August 27 to September 4, 2026.
Regulation | 08/09/2026 | By News Bureau | 116
Maharashtra FDA Conducts 2,902 Inspections, Acts Against 880 Drug Licence Holders
Maharashtra FDA’s intensified inspections identified compliance gaps across pharmaceutical manufacturing, sales, blood centres and storage facilities.
Regulation | 08/09/2026 | By News Bureau
Lupin Receives US FDA Approval for Modafinil Tablets, USP
Lupin receives US FDA approval for Modafinil Tablets USP, 100 mg and 200 mg, bioequivalent to Provigil for the US market.
Regulation | 07/09/2026 | By News Bureau
US FDA Approves ZANVASTRO as First Disease-Modifying Treatment for Alexander Disease
The US Food and Drug Administration (FDA) approves ZANVASTRO (zilganersen) as the first disease-modifying treatment for Alexander Disease (AxD) in pediatric and adult patients.
Regulation | 05/09/2026 | By News Bureau
US FDA Approves ETCAMAH Plus CDK4/6 Inhibitor for Advanced HR-Positive Breast Cancer
US approves ETCAMAH (camizestrant) plus a CDK4/6 inhibitor for first-line advanced HR-positive breast cancer, reducing progression or death risk by 56 percent.
Regulation | 05/09/2026 | By News Bureau
Milestone's Etripamil Nasal Spray Wins China NMPA Approval for PSVT
Milestone Pharmaceuticals’ etripamil nasal spray receives China NMPA approval for PSVT, triggering a USD 2 million payment and expanding access in Greater China.
Regulation | 05/09/2026 | By News Bureau
US FDA Approves Treatment for Essential Thrombocythemia
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia, with a recommended starting dose of 250 mcg.
Regulation | 02/09/2026 | By News Bureau
The European Union (EU) has approved Enhertu plus pertuzumab as a new first-line regimen for HER2-positive metastatic breast cancer, reducing progression or death risk by 44 percent.
Regulation | 02/09/2026 | By News Bureau
US FDA Approves Gilead's Bixlenvo for Once-Daily HIV Treatment
The US Food and Drug Administration (FDA) approves Gilead’s Bixlenvo, a once-daily single-tablet HIV treatment combining bictegravir and lenacapavir for virologically suppressed adults.
Regulation | 01/09/2026 | By News Bureau
US FDA Approves First Drug for Polycythemia Vera
The US Food and Drug Administration (FDA) has approved the first-in-class drug for polycythemia vera, targeting the underlying biology driving excessive Red Blood Cell (RBC) production.
Regulation | 31/08/2026 | By News Bureau
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