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news.Merck provides regulatory update on bezlotoxumab biologics licensing application
The additional data and analyses constitute a major amendment to the BLA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three
The additional data and analyses constitute a major amendment to the BLA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three
Maud Brandely, Chief Medical Officer of Transgene, said: “We are pleased to be continuing the development of our internally discovered and developed immunotherapy TG1050. The Phase 1/1b trial
“This agreement highlights the great expectation for nemolizumab which possesses a novel mechanism of action to improve atopic dermatitis by breaking the itch-scratch cycle,” said Chugai’s Representative Director,
Upon completion and once fully evaluated, which is expected to take approximately 9-12 months, this clinical trial material will also be available to recommence dosing of patients in the Company’s
In conjunction with the financing, Andrew Levin, M.D., Ph.D., managing director of RA Capital Management, will join Synthorx’s board of directors. Leveraging a synthetic biology breakthrough, Synthorx has
Under the terms of the agreement, Sapience will gain exclusive rights to the development and commercialization of intellectual property developed at Columbia University by Drs. Lloyd Greene and
West-Ward's Capecitabine Tablets are indicated for adjuvant treatment in patients with Dukes' C colon cancer, as monotherapy in metastatic colorectal cancer, and in combination with docetaxel or as
Under the terms of the agreement, PeptiDream will receive an undisclosed upfront payment, annual technology access payments, and is eligible to receive payments based on achievement of certain
Fast Track designation is granted by FDA to drugs that are under development for serious conditions and have the potential to fulfill an unmet medical need. It was
With the new indication, patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg), can now start combination therapy directly with