Astellas said in a press release that the FDA comments in the CRL relate to proposed labeling language, not safety.

JPMorgan says Astellas Pharma’s (ALPMY) (ALMPY) announcement that the FDA has issued a Complete Response Letter regarding for Izervay in ...

Astellas Pharma (ALPMY) announced the Food and Drug Administration issued a Complete Response Letter regarding the supplemental new drug ...

The FDA rejected an application from Astellas seeking to change the prescribing label for its eye drug Izervay to allow less ...

"Astellas stands by the clinical profile of Izervay, the only FDA-approved GA treatment that consistently demonstrated ...

Many companies just iterate indefinitely without ever making progress toward an actual drug,” said one biotech VC on a panel ...

Roughly a year ago, Gilead Sciences revealed that it was laying off about 7% of Kite Pharma’s workforce in a bid to refresh ...

Astellas Pharma Inc. (OTCMKTS:ALPMY – Get Free Report) saw a large decrease in short interest in the month of October. As of October 31st, there was short interest totalling 9,100 shares ...

The proven Zacks Rank system focuses on earnings estimates and estimate revisions to find winning stocks. Nevertheless, we know that our readers all have their own perspectives, so we are always ...

PITTSBURGH--KaliVir Immunotherapeutics, Inc., a clinical-stage biotechnology company developing cutting-edge, multi-mechanistic oncolytic viral immunotherapy programs, today announced the expansion of ...

The company has discontinued the Phase I/II trial of its only clinical candidate due to a potential “unfavourable ...