Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis

UPM Biomedicals enters into distribution agreement with Brinter for GrowInk bioinks

The agreement grants Brinter the distribution rights of GrowInk bioinks in many countries

Hikal receives Brazilian GMP certification and USFDA EIR for Bangalore and Panoli facilities

SMi discloses £6 million seed funding round, bolsters team with new C-suite hire

Investment enables development of revolutionary multi-omic platform using super-resolution imaging technology for earlier disease detection and accelerated discovery of therapeutics

Innovent announces 2nd BTD by NMPA for Olverembatinib for treatment of patients with SDH-deficient GIST

Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors

Zydus granted Orphan Drug Designation by USFDA for ZYIL1

ZYIL1 is a novel oral small molecule NLRP3 inhibitor which has demonstrated CSF penetration in non-human primates

USFDA accepts for priority review the sNDA for Merck’s Prevymis

FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients

Pfizer announces Talzenna and Xtandi combination data from phase 3 study

Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI

Quantumzyme and BEC Chemicals to collaborate for green chemistry development

This will give either party customers access enzyme expertise and assets, resulting in cost-effective, green processing for API manufacturing.

European Commission approves SPEVIGO for generalized pustular psoriasis flares

EC grants conditional marketing authorization based on the EFFISAYIL trial