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
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
Drugs
Health
Pharma
Roche’s Covid-19 antibody treatment gets FDA approval
Roche's Actemra is the first FDA-approved monoclonal antibody to treat COVID-19
Health
Medical
Philips says tests on recalled respiratory devices show limited health risks
Philips says its independent tests on recalled respiratory devices found limited health risks for users.
Drugs
Medical
FDA approves gene therapy for treatment of high-risk bladder cancer
The FDA approved Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector-based gene therapy for the treatment of high-risk bladder cancer.
Drugs
Pharma
Sun Pharma’s facility listed under FDA import alert
Indian drugmaker Sun Pharmaceutical Industries, facility in western Gujarat state, has been listed by the Food & Drug Administration under "import alert," according.