Lupin arm recalls 5,720 tubes of Clobetasol propionate Cream in US over manufacturing issue Ruchika Sharma6 Feb 2023 11:26 AM ISTThe USFDA noted that the company is recalling the affected lot due to "Subpotent Drug: Low assay result observed during long-term stability testing".
Natco Pharma gets 2 observations from USFDA for Vizag facility Ruchika Sharma5 Feb 2023 1:00 PM ISTHyderabad: Natco Pharma Limited has announced the completion of a regulatory inspection from the United States Food and Drug Administration (USFDA)...
USFDA nod to Takeda TAKHZYRO to prevent Hereditary Angioedema attacks in children 2 years of age and older Ruchika Sharma4 Feb 2023 1:15 PM ISTHereditary angioedema (HAE) is a rare genetic disorder that results in recurring attacks of edema - swelling - in various parts of the body, including...
Gilead Sciences secures USFDA okay for Trodelvy for pre-treated HR+/HER2- Metastatic Breast Cancer Ruchika Sharma4 Feb 2023 11:37 AM ISTTrodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate.
Central, state teams on way to Global Pharma Healthcare plant after firm recalls eye drop linked to vision loss in US Ruchika Sharma4 Feb 2023 9:45 AM ISTThe USFDA noted that the "use of contaminated Artificial Tears can result in the risk of eye infections that could result in blindness".
AstraZeneca Tezspire approved for self administration in US with new pre filled pen Ruchika Sharma3 Feb 2023 12:15 PM ISTThe Tezspire pre-filled pen enables patients and caregivers to self-administer the medicine at home or in clinic via a simple process.
USFDA grants Orphan Drug Designation to GSK Benlysta for systemic sclerosis Ruchika Sharma2 Feb 2023 1:15 PM ISTSystemic sclerosis (SSc) is a rare autoimmune disease that causes atypical growth of connective tissues and can affect the musculoskeletal system,...
USFDA removes COVID test requirements for Merck, Pfizer pills Ruchika Sharma2 Feb 2023 12:15 PM ISTThe health regulator said individuals with recent known exposure with signs and symptoms may be diagnosed by their healthcare providers with COVID...
GSK bags USFDA okay for Jesduvroq for anaemia of chronic kidney disease in adults on dialysis Ruchika Sharma2 Feb 2023 11:20 AM ISTJesduvroq provides an oral treatment option for adult patients with anaemia of CKD on dialysis.
Moderna gets USFDA Breakthrough Therapy Designation for RSV vaccine Ruchika Sharma1 Feb 2023 4:00 PM ISTmRNA-1345 is an investigational RSV vaccine that consists of a single mRNA sequence encoding for a stabilized prefusion F glycoprotein.
Jubilant Draximage bags USFDA nod for Technetium Mertiatide Injection Ruchika Sharma1 Feb 2023 12:15 PM ISTNoida: Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc has announced that it has received approval from the US Food...
Lupin bags tentative USFDA nod for Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets to control HIV infections Ruchika Sharma31 Jan 2023 3:30 PM ISTMumbai: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug...
