News

The FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 15, 2020. “The FDA’s acceptance of our application

Under the terms of the agreement, each company will contribute their individual expertise in a highly collaborative manner to discover novel antibody therapeutics. Specifically, Schrödinger will use its

The Japan Ministry of Health, Labour and Welfare (MHLW) has approved Dovato to treat HIV-1 infection in adults and adolescents above12 years of age with a minimum of

As per the terms of the deal, the Japanese pharma company and Adaptimmune will select up to three targets for their collaboration and will co-develop T-cell therapy candidates

The organizations will form co-owned, joint development companies (“JDCs”) that will integrate Atomwise’s AI technology and BioMotiv’s deep expertise in preclinical and clinical development to translate innovative academic

Together, Charles River and Takeda will launch multiple integrated programs across Takeda’s four core therapeutic areas—oncology, gastroenterology, neuroscience, and rare disease—with the ultimate goal of delivering preclinical candidates

Ovaprene is Daré’s investigational hormone-free monthly vaginal contraceptive, which is under clinical development to prevent pregnancy. Under the exclusive licence agreement, Bayer will commercialise Ovaprene after it is

Under the marketing authorisation application (MAA) submitted to the European Medicines Agency (EMA), the company has asked the regulator to review the potential use of fostemsavir in combination

The rolling submission allows completed sections of an NDA to be reviewed by the FDA on an ongoing basis. Specifically, Alnylam has submitted the non-clinical components to the