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The designation has been awarded for IDE161 to treat adult patients with advanced or metastatic hormone receptor-positive (HR+), Her2- breast cancer with germline or somatic BRCA 1/2 mutations.

The regulator also approved LIKMEZ as the brand name for ATI-1501. Saptalis is a manufacturing and commercialisation partner of Appili Therapeutics, which has developed ATI-1501 as a liquid

ALTUVIIIO, also known as efanesoctocog alfa, is an antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein used for perioperative management of bleeding, controlling bleeding episodes, and routine prophylaxis. The recommended

This acquisition aligns with Lupin’s strategic goal to strengthen its position in the key therapeutic portfolio in India. The brands agreed to be acquired consists of Piclin (Picosulphate

The company submitted the application in August this year seeking approval for the initiation of Phase I clinical trial of KB408. The regulator, after the 30-day review of

With an area of around 7,000m2, the new location features the XBCM2 dual-function facility for bioconjugate drug substance and antibody intermediates production. It also comprises the XDP2 facility,

Cabotegravir is indicated for use in high-risk adults and adolescents aged a minimum of 12 years weighing at least 35 kg. It is claimed to be the first

KT-333 is a highly selective degrader of STAT3, a transcriptional regulator that is linked to inflammatory and autoimmune diseases as well as various cancers. The company is also

A Final Draft Guidance (FDG) has been issued for QUVIVIQ for the treatment of these patients with symptoms lasting for three nights or more per week for at