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news.FDA Classifies Cadence Ofirmev Injection NDA As Class 2 Response
Cadence said that on February 10, 2010, it received a complete response letter from the FDA which indicated that the Ofirmev NDA could not be approved due to
Cadence said that on February 10, 2010, it received a complete response letter from the FDA which indicated that the Ofirmev NDA could not be approved due to
As per the terms of the agreement, Merck is expected to pay ElexoPharm an upfront payment of EUR1.5m. In addition ElexoPharm will be eligible to receive up to
Patients diagnosed with the rare light and UV intolerance erythropoietic protoporphyria (EPP) will now be able to gain access to the photoprotective drug – known under the generic
Mr Spaight is expected to oversee WIL’s four major businesses – WIL Research Laboratories, Notox, Midwest BioResearch and QS Pharma, and will continue to implement a long-term strategy
BioSante Pharma said that by incorporating 2A/Furin technology into antibody-expression in viral vectors it is possible to rapidly generate stable, high producing antibody cell lines. The subsequent cell
Earlier, NeoPharm had filed an investigational new drug application (IND) with the FDA for IL13-PE38QQR (IL13-PE) for the treatment of Idiopathic Pulmonary Fibrosis (IPF), on Jan 04, 2010.
Sprix is a prescription intranasal formulation of the analgesic ketorolac, a non-steroidal anti-inflammatory drug (NSAID), designed to provide ambulatory patients with a convenient, potent, and fast-acting option for
As per the decision, the Changzhou FDA is expected to impose a fine of RMB25.6m consisting of penalties and confiscated revenues from previous sales of substandard quality human
Emerging World Pharma said that by complying with the WHO manufacturing standards, African Global Pharma will be eligible for various grants and funding. Brandon Keks, president of Emerging
Sodium lauryl sulfate (SLS) is a frequently used tabletting aid that works as a wetting agent, lubricant or solubilizer. GRAS status is recognition that Texapon K 12 P