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The FDA in the CRL said it focused on issues with third-party Lymphoseek contract manufacturing and was not in relation to any efficacy or safety data filed within

The Phase 1 of the study will enrol up to 52 patients and monitor depletion of androgen receptors in tumour and Circulating Tumour Cells samples following treatment with

As part of the JV, MedImmune will provide technical and development support while WuXi AppTec will provide local regulatory, manufacturing, pre-clinical and clinical trial support. MedImmune Research and

The new instrument control software is available as a developer’s kit for Q Exactive LC/MS customers who want to acquire DIA capability, according to the company. The DIA

The drugs are expected to be supplied early in the next month in a limited quantity, according to Novartis CEO. The Lincoln plant reportedly has been shut down

The Amlodipine Besylate and Benazepril Hydrochloride Capsules are the generic bioequivalent to the reference listed drug Lotrel Capsules of Novartis Pharmaceuticals. The products, indicated for the treatment of

Tolterodine is a generic version of Detrusitol (tolterodine) while Tolterodine XL (Mariosea XL) is a generic version of Detrusitol XL (tolterodine XL) from Pfizer, both indicated for the

The new plant will manufacture and distribute insulin, a diabetes product. The plant is expected to produce nearly 1,500kg/y of insulin or around 45m vials. Julphar also said

Crofelemer is designed to provide symptomatic relief of non-infectious diarrhea in patients with HIV/AIDS on anti-retroviral therapy. Salix chief development officer and medical, research and development executive vice