Oncology

Trodelvy granted accelerated approval by USFDA for metastatic urothelial cancer

Gilead Sciences has announced the accelerated approval of Trodelvy (or sacituzumab govitecan-hziy) by the US Food and Drug Administration (FDA) in the treatment of locally advanced or metastatic urothelial cancer (UC) in adult patients.

Sanofi acquires Tidal Therapeutics

Global biopharmaceutical company Sanofi has acquired privately owned, pre-clinical stage biotech company Tidal Therapeutics, which brings with it an mRNA-based approach for in vivo (inside the body) reprogramming of immune cells.

Anixa and OntoChem enter next stage of Covid-19 anti-viral therapy development

Biotechnology company Anixa Biosciences, partnered by IT and pharma solutions company OntoChem, has announced that it will enter the next stage of development of its potential anti-viral therapy for Covid-19.

USFDA sends CRL to Merck’s sBLA regarding KEYTRUDA

Merck has announced that the US Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) regarding Merck’s supplemental Biologics License Application (sBLA) for the approval of KEYTRUDA.

Ambrx gets orphan drug designation for gastric cancer treatment ARX788

The US Food and Drug Administration (FDA) grants orphan drug designation to Ambrx for ARX788, a homogeneous and highly stable antibody drug conjugate, for the treatment of HER2-positive gastric cancer.

USFDA grants priority review to Merck’s NDA for HIF-2α inhibitor Belzutifan

The US Food and Drug Administration (FDA) has granted priority review for Merck’s New Drug Application (NDA) for the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor belzutifan.

Enveric Biosciences signs licensing agreement with Diverse Biotech

Enveric Biosciences has announced that it has signed an exclusive, perpetual licensing agreement with Diverse Biotech to develop new molecules for the treatment of cancer and other debilitating diseases.

Japan’s Takeda to acquire the US’ Maverick Therapeutics

Japan-based Takeda Pharmaceutical Company Limited has entered into an agreement to acquire private biopharmaceutical company Maverick Therapeutics, Inc. in a bid to expand its novel immuno-oncology portfolio.

USFDA approves Libtayo for skin cancer treatment

The US Food and Drug Administration (FDA) has approved Libtayo to be used for the treatment of patients having two of the most common skin cancers in the US.