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August 13, 2020
The company has launched its biosimilar rituximab, Ritucad, for the Indian market.
FDA has approved Evrysdi (risdiplam) for treating spinal muscular atrophy in adults and children.
The companies received approval from the EC for Zercepac (HLX02), a biosimilar referencing Roche’s originator biologic, Herceptin (trastuzumab).
The committee has given a positive opinion on the biosimilar bevacizumab for several cancer indications.
August 11, 2020
The guidance is intended to assist IND sponsors in determining the need for drug-drug interaction studies.
August 10, 2020
The White House initiative to encourage production of essential medicines in the United States calls on FDA to set the parameters for and implement main aspects of the program.
August 07, 2020
Roche has received approval from the European Commission for Rozlytrek (entrectinib), its newest anti-cancer drug, for two indications.
The European Medicines Agency recently approved two European Novartis sites in France and Switzerland for the commercial manufacturing of chimeric antigen receptor T-cell cell therapies.
August 05, 2020
FDA sent a warning letter to ACRX Specialty Pharmacy Inc. detailing violations of the Federal Food, Drug, and Cosmetic Act and deficiencies in sterile manufacturing practices.
The document gives guidance on the limited population pathway for antibacterial and antifungal drugs.