Alnylam Pharmaceuticals’ investigational RNAi therapeutic givosiran has been granted priority review by the US Food and Drug Administration (FDA) for the treatment of acute hepatic porphyria (AHP).
Daiichi Sankyo has secured approval from the US Food and Drug Administration (FDA) for the use of Turalio (pexidartinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT).
GlaxoSmithKline (GSK) has secured marketing authorisation from the European Commission (EC) for two new administration options of Nucala (mepolizumab) to treat patients with severe eosinophilic asthma.
Bayer has secured approval from the US Food and Drug Administration (FDA) for its Nubeqa (darolutamide) to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine.
NeuroVive Pharmaceutical AB announced that the company's candidate drug NeuroSTAT, in development for treatment of moderate to severe traumatic brain injury, TBI, has received Fast Track designation from the US Food and Drug Administration, FDA, facilitating its clinical development and path forwards to market.
Roche’s Tecentriq (atezolizumab) and chemotherapy combination has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of two types of lung cancer.
Epizyme announced that the US Food and Drug Administration (FDA) has accepted for filing the company’s New Drug Application (NDA) for accelerated approval of tazemetostat, its lead investigational agent.
Merck and Eisai have been granted breakthrough therapy designation from the US Food and Drug Administration (FDA) for their Keytruda and Lenvima combination for unresectable hepatocellular carcinoma (HCC).
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Ruxience (rituximab-pvvr), a biosimilar to Roche’s cancer drug Rituxan (rituximab), to treat certain cancers and autoimmune conditions.
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