Biocon gets EIR from USFDA for Bengaluru biologics unit Medical Dialogues Bureau6 Nov 2019 9:19 AM ISTNew Delhi: Biopharmaceutical firm Biocon on Tuesday said it has received an establishment inspection report (EIR) from the US health regulator for its...
Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility Medical Dialogues Bureau5 Nov 2019 12:57 PM ISTNew Delhi: Drug firm Zydus Cadila on Monday said it has received a warning letter from the US health regulator for its Moraiya-based formulation...
Sun Pharma Advanced Research Company Q2 loss widens to Rs 63 cr Medical Dialogues Bureau5 Nov 2019 12:55 PM ISTNew Delhi: Sun Pharma Advanced Research Company (SPARC) on Monday reported a net loss of Rs 63.16 crore for the quarter ended September 30 of the...
Unichem Labs net loss narrows to Rs 22 crore in September quarter Farhat Nasim5 Nov 2019 9:15 AM ISTUnichem Labs had posted a net loss of Rs 41.03 crore for the corresponding period of the previous fiscal, the company said in a filing to the BSE.New...
DoP invites nominations for 5th India Pharma and Medical Device Awards Medical Dialogues Bureau4 Nov 2019 5:23 PM ISTNew Delhi: The Government of India, Ministry of Chemicals & Fertilizers, Department of Pharmaceuticals (DoP) has decided to confer 5th India...
Strides Pharma Ranitidine tablets within acceptable NDMA limits, says USFDA Medical Dialogues Bureau4 Nov 2019 4:31 PM ISTNew Delhi: Drug firm, Strides Pharma recently announced that the USFDA issued a statement1 on November 1, 2019, providing an update with the latest...
GSK Benlysta gets European nod for treatment of children with lupus Medical Dialogues Bureau4 Nov 2019 9:15 AM ISTNew Delhi: GlaxoSmithKline (GSK) plc recently announced that the European Commission has adopted a decision to extend to children five years and...
AbbVie says multiple parties vying for assets related to Allergan deal approval Medical Dialogues Bureau4 Nov 2019 9:00 AM ISTAbbVie Inc said it had notified the U.S. antitrust watchdog of its intention to divest its experimental inflammatory bowel disease therapy,...
CDSCO, Saudi Food and Drug Authority ink agreement for medical products regulations Medical Dialogues Bureau3 Nov 2019 10:24 AM ISTAn MoU was signed between the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare and Saudi Food and Drug...
Indoco Remedies gets USFDA ANDA nod for Glycopyrrolate Injection Medical Dialogues Bureau3 Nov 2019 10:00 AM ISTGlycopyrrolate is indicated for use as a preoperative antimuscarinic to reduce salivary, tracheobronchial, and pharyngeal secretions; to reduce the...
Stempeutics gets patent for stem cell drug Stempeucel from US Patent and Trademarks Office Medical Dialogues Bureau3 Nov 2019 9:55 AM IST"The US patent is for the method of treating ischemia by administering pooled allogeneic mesenchymal stromal cells," Stempeutics Research said in a...
Another delay in USD 2.1 million gene therapy Zolgensma data reporting, Novartis admits mistake Medical Dialogues Bureau3 Nov 2019 9:45 AM ISTThe USFDA on Wednesday placed a partial hold on a Novartis trial of the $2.1 million-per-patient gene therapy, Zolgensma after the company informed...