5 March 2021 - Yescarta is the first CAR T-cell therapy approved for indolent follicular lymphoma; approval marks the third ...
4 March 2021 - The U.S. FDA previously granted priority review designation to Actemra for the treatment of systemic sclerosis-associated ...
3 March 2021 - The application includes robust data from the Phase 3 registration program, which demonstrated efficacy of daridorexant ...
5 March 2021 - New legislation has been passed to allow pharmacists to substitute a different medicine when a patient's ...
5 March 2021 - TGA has adopted guidance developed by the Access Consortium - a coalition of regulatory authorities from ...
3 March 2021 - Blueprint Medicines today announced that the EMA has validated the company's type II variation marketing authorisation application ...
3 March 2021 - BLA submitted with FDA’s breakthrough therapy designation. ...
2 March 2021 - The Accu-Joint is indicated for use in the treatment of patients with degenerative and post-traumatic arthritis in ...
4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...
4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...
4 March 2021 - MedAlliance has now been awarded breakthrough status for SELUTION SLR, its sustained limus release DEB catheter, in ...
3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...
4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...
2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...
3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...