The FDA grants ODD status to medicines and potential new medicines intended for the treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
Phase 1/2 trial of E-602 expected to open in Q1 2022 in patients with solid tumours
First launches expected in H1 2022
The company has 47 ANDA's pending approval with the U.S.FDA
In-house wet testing with live Omicron virus demonstrated that the Antigen test detects the Omicron variant with comparable sensitivity to other variants
Health experts of the country have pointed out that the benefits of the drug outweigh the potential risks it may have in the case of high-risk patients
Topline results from the randomized EMPATHY Part A study in acute Covid-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo, met the primary endpoint of viral load reduction over eight days
Simulated Moving Bed (SMB) technology is a highly engineered process for implementing chromatographic separation
Despite the challenges of pandemic disruptions, drug developers advance promising therapies for conditions, including Alzheimer's, diabetes and asthma
Subscribe To Our Newsletter & Stay Updated
