MHRA approves UK’s first new type of antibiotic for urinary tract infections
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
As with any medicine, the MHRA will keep the safety of gepotidacin under close review
LHP588 is an oral, brain-penetrant lysine-gingipain (Kgp) inhibitor designed to block the key virulence factor of P. gingivalis
VYVGART was well tolerated, with a safety profile consistent with prior studies in AChR-Ab seropositive gMG and other indications
The new lineup includes CereTom Elite, OmniTom Elite, OmniTom Elite PCD, and BodyTom 32/64
This authorization follows FDA approval in June and WHO’s July recommendation adding twice-yearly lenacapavir as a PrEP option
The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations
Delegates also visited Emami’s WHO-GMP-certified manufacturing plant and Zandu Foundation for Healthcare farms for hands-on exposure to quality practices,
The first pillar is advanced manufacturing, focused on upgrading existing CDMO
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