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.
Baxter International has secured approval from the US Food and Drug Administration (FDA) for its Myxredlin (insulin human in 0.9% sodium chloride injection).
Johnson & Johnson’s Janssen Pharmaceutical is seeking extension of approval in the European Union for Darzalex (daratumumab) in a subcutaneous formulation for the treatment of multiple myeloma.
The Chinese National Medical Products Administration (NMPA) approved Gilenya for relapsing forms of multiple sclerosis (RMS) for adults and children 10 years and older.
Celgene has secured approval from the US Food and Drug Administration (FDA) for its Otezla (apremilast) 30mg twice daily (BID) to treat adult patients with oral ulcers associated with Behçet’s Disease.
LifeMax Laboratories, a private company focused on treating rare diseases with few or no therapeutic options, announced that the Food & Drug Administration (FDA) granted rare pediatric disease designation to LM-030, an investigational therapy licensed from Novartis and ready to enter into pivotal clinical trials for the treatment of Netherton Syndrome.
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