GSK Plc gets FDA nod to make oral drug for anaemic CKD patients
GSK Plc., a British global pharmaceutical company, announced the FDA had approved an oral drug to treat anaemia arising from chronic kidney disease.
Drugs
Medical
Pharma
Drugs
Medical
Pharma
Eli Lilly gets FDA nod for blood cancer drug
Eli Lilly announced that it had received US FDA approval for a tablet to treat a rare form of blood cancer.
Drugs
Medical
Pharma
US health regulator says heart devices recall “most serious”
A recall of Swedish makers' of heart devices has been classified by the FDA as "most serious" since they could lead to severe.
Drugs
Pharma
Eli Lilly plans $450 million extra to expand Research Triangle
Eli Lilly will invest an additional $450 million to expand its manufacturing capacity at Research Triangle Park facility in North Carolina.
Drugs
Pharma
USFDA grants ‘tentative approval’ to Zydus’ mental health drug
The USFDA has granted Zydus Lifesciences Limited ‘tentative approval’ to market Levomilnacipran extended-release capsules in 20 mg, 40 mg, 80 mg, and 120.
Drugs
Pharma
Eiasi files market authorization for Alzheimer’s drug in Japan
Eiasi Co., a Japanese pharmaceutical company, has submitted a marketing authorization application for a drug, lacanemab, to treat Alzheimer's disease.
Drugs
Pharma
US drug regulator issues warning letter to Sun Pharma on CGMP
Indian drug major Sun Pharmaceutical’s western Indian facility of Halal has been issued a warning letter by the FDA for not conforming to Current Good.
Drugs
Pharma
FDA gives accelerated approval for Alzheimer’s drug
The FDA has granted accelerated approval for an intravenous drug to treat Alzheimer's Disease, according to a statement.
Drugs
Pharma
Aurobindo Pharma gets FDA nod for injection to treat cancer
Aurobindo Pharma announced that its fully-owned subsidiary, Eugia Pharma Specialities, received final approval from FDA to make and market Azacitidine injection for cancer.
Drugs
Pharma
Plan B contraceptive pill not an abortion drug, states FDA
FDA amends Plan B contraceptive pill label to state that it does not harm a fertilized egg and is not an abortion drug