Tag: FDA
FDA clears imaging drug to evaluate myocardial ischemia & infarction
The US Food and Drug Administration has approved Flyrcado (flurpiridaz F 18) in adult patients with known or suspected coronary artery disease (CAD) to...
FDA approves first gene therapy for Metastatic Synovial Sarcoma
The US Food and Drug Administration has approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic...
FDA approves first gene therapy for Metastatic Synovial Sarcoma
The US Food and Drug Administration has approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with unresectable or metastatic...
US FDA approves Sun Pharma’s Leqselvi
Sun Pharmaceutical has announced that the US Food and Drug Administration (FDA) approved its Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults...
FDA approves new treatment for uncomplicated UT infections
The US Food and Drug Administration (FDA) has approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs)...
Gerresheimer’s Gx Value, Gx Advance and Gx Elite performance levels
Gerresheimer, a system and solution provider and a global partner for the pharma, biotech and cosmetic industries, has presented its new performance levels for...
Lyrus’ UTI treatment drug gets US FDA approval
The US Food and Drug Administration (FDA) has approved Lyrus Life Sciences’s Abbreviated New Drug Application (ANDA) for ‘Methenamine Hippurate Tablets USP, 1 gram’....
Biopharmaceuticals packaging trends: A future in focus
The global biopharmaceutical packaging market is anticipated to accumulate a market value of US$ 18.87 billion in 2023 and is expected to garner a...
FDA tentative approval for Viatris HIV drug
Viatris Inc., a global healthcare company with a center in India, on 5 September announced the US Food and Drug Administration's (FDA) tentative approval...
Fresio Herbals – manufacturer to market place in one go
Fresio Herbals, a 'manufacturer to market place' service provider, recently participated in the Cosmohome Tech expo held from 19 – 21 July at Pragati...