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FDA’s Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need. A drug development program with Fast

TTIL will support a Phase 2 study to evaluate selective androgen receptor modulator (SARM) drug candidate TT701 as a therapy to improve the symptoms of androgen deficiency in

Under the agreement, WuXi will equip and operate a dedicated, fully cGMP-compliant 12,500-square-foot analytical testing facility in Shanghai. The facility will provide analytical and stability services, including analytical

Pfizer’s current PCMM prototype is an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional

Vidaza is indicated to treat adult patients aged 65 years or older with AML who are not eligible for haematopoietic stem cell transplantation (HSCT). The commission updated Vidaza

The 150-subject, randomized, open-label, multi-center clinical trial will compare the combination regimen to RICE alone. The primary endpoint is the comparison of complete remission rates between the two

Allergan said it had been approached by Pfizer and is in preliminary friendly negotiations with respect to a potential business combination. The company said no agreement has been

Utibron Neohaler (indacaterol/glycopyrrolate), which is expected to be available in the first quarter of next year, can be used for the long-term maintenance treatment of airflow obstruction in

This trial is the first to evaluate the safety and efficacy of OCA in Japanese NASH patients. The primary efficacy analysis was conducted on an intention to treat