US FDA grants Orphan Drug Designation to BCMA CAR-T cell therapy co-developed by Innovent Biologics…
ODD will accelerate drug development and registration action in the US
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Browsing Tag
US FDA approval
US FDA authorises Eli Lilly’s COVID-19 antibody drug
The FDA authorised bebtelovimab for emergency use in patients with mild-to-moderate COVID-19 who are at high risk of progression…
Zydus gets 180 days’ shared exclusivity for Roflumilast tablets
Zydus’ Roflumilast tablets are indicated as a treatment to reduce the risk of Chronic Obstructive Pulmonary Disease (COPD)…
Lupin receives approval from US FDA for Arformoterol Tartrate inhalation solution
Arformoterol Tartrate inhalation solution 15 mcg (base)/2 ml, unit-dose vials are indicated for the long-term maintenance…
Theseus Pharmaceuticals receives US FDA Orphan Drug Designation for THE-630 to treat Advanced…
For patients living with GIST, progression through standard lines of therapy is often associated with the emergence of resistance…
Alembic Pharma receives US FDA tentative approval for Fesoterodine Fumarate extended-release tablets
The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Toviaz extended-release…
FDA approves Roche’s Vabysmo to treat nAMD and DME
Vabysmo is the only injectable eye medicine approved simultaneously in the US for neovascular Age-related Macular Degeneration…
Glenmark gets nod from US FDA for generic drug
The product is a generic version of Bausch Health US LLC's MetroGel-Vaginal
US FDA approves second indication for Skyrizi to treat adults with active psoriatic arthritis
Skyrizi maintains a dosing regimen for PsA that is consistent with the existing regimen for moderate-to-severe plaque psoriasis…
Zydus receives final approval from US FDA for Vigabatrin tablets
Vigabatrin is used to treat babies, one month to two years old with infantile spasms