US FDA approval

Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine, given intramuscularly in two doses, was initially approved by FDA…

VAXNEUVANCE demonstrated non-inferior immune responses for the serotypes shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,…

It is a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained eGFR…

US clearance stalled after the US FDA questioned "unresolved facility inspection-related conditions" at the Italian plant of…

The parties have received final approval for 10 mg and 60 mg strengths of the product and tentative approval for 30 mg strength of…

Brivaracetam is used to treat partial-onset of seizures (epilepsy)

First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive…

In DAPA-CKD Phase III trial, FARXIGA demonstrated reduction in the risk of the composite of worsening of renal function, end-stage…

Foscarnet Sodium Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with AIDS

Trodelvy significantly reduced the risk of death by 49 per cent compared with single-agent chemotherapy in the Phase 3 ASCENT…