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Seagen forged an exclusive licensing agreement with China’s RemeGen Co., Ltd, to develop and commercialize disitamab vedotin, a novel HER2-targeted ADC.
Sanofi has announced that the U.S. FDA approved its new treatment for children one year of age or older diagnosed with late-onset Pompe disease.
The company indicated they plan to meet with the FDA to determine the next course of action.
The acquisition of OtiTopic will boost the company’s new strategy and potentially address a significant unmet medical need in more than 83 million people in the U.S. with myocardial infarction.
Called “female Viagra” in the media, Ovoca Bio’s BP-101 (Libicore) nasal spray therapy for low libidos in premenopausal women is undergoing Phase II trials.
As COVID-19 vaccines near full approval by the U.S. FDA, Dr. Anthony Fauci expects several organizations across the country, including businesses and schools, will issue their own vaccine mandates before people can enter their establishments.
The clinical study compared Enhertu to Kadcyla in HER2+ metastatic breast cancer patients who previously received trastuzumab.
Although August is a fairly busy month for PDUFA dates, there were only two on the U.S. FDA’s calendar for this week, and one of those has already been reported. Here’s a look.
The co-head of a Phase III trial reported Johnson & Johnson’s single-shot COVID-19 vaccine was highly effective at preventing severe disease, including among patients infected with the circulating Delta coronavirus variant.
Oyster Point Pharma inked a license and collaboration deal with Ji Xing Pharmaceuticals to develop and market OC-01 (varenicline) and OC-02 (simpinicline) nasal sprays for dry eye disease in Great China.
The deal will give EQRx a pre-transaction enterprise value of $3.65 billion and an immediate $1.8 billion in cash that will be used to advance the development of the company’s pipeline.
Sierra will have access to AZD5153, a potent and selective BRD4 BET inhibitor, to initiate a study that combines the said component with momelotinib for treating patients with myelofibrosis.