US FDA approves Viltepso injection for treatment of Duchenne muscular dystrophy mutation
The approval was granted to NS Pharma
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Tag
US FDA
American Gene Technologies gets US FDA nod for Phase 1 clinical trial of potential HIV cure
AGT’s Phase 1 trial will investigate the safety of AGT103-T, a single-dose, lentiviral vector-based gene therapy, and measure key…
Lupin launches Zileuton extended-release tablets
This tablet is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older
Roche gets US FDA approval for Evrysdi to treat spinal muscular atrophy
In two clinical trials, Evrysdi improved motor function in people living with SMA over a broad spectrum of ages and levels of…
Gilead seeks full approval for remdesivir from US FDA for COVID-19 treatment
To boost the drug’s availability globally, Gilead has signed multiple manufacturing and supply deals, including with Pfizer and…
Dr Reddy’s Laboratories launches generic Ciprodex Otic Suspension, USP in US
It is available as 7.5 mL fill in a 10 mL bottle
Lupin, Sun Pharma recall drugs in US market
Lupin is recalling 11,688 bottles of Lisinopril tablets USP, 10 mg while Sun Pharma is recalling 3,516 bottles of Clonazepam…
Lupin, Concord, receive US FDA approval for Mycophenolate Mofetil tablets USP
They are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in…
Indoco gets USFDA approval for Olanzapine tablets
Olanzapine is indicated for the treatment of schizophrenia and bipolar disorder
FDA finalises guidance, ‘Limited Population Pathway for Antibacterial and Antifungal Drugs’
This guidance is intended to assist sponsors in developing labelling, including prescribing information, patient labelling, and…