FDA authorises Utility Therapeutics’ Pivya tablets for UTIs
The approval was based on results from three controlled clinical trials of females aged 18 and above in…
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25 Apr 24
The approval was based on results from three controlled clinical trials of females aged 18 and above in…
25 Apr 24
The approval was based on the results from the Phase 3 PROTECT study which reached its primary endpoint…
24 Apr 24
The competing lawsuits over Covid-19 vaccines are a part of the ongoing litigation worldwide, centred around mRNA technology,…
23 Apr 24
Emblaveo underwent review through the EMA accelerated assessment procedure, which is employed for pharmaceutical products deemed of significant…
23 Apr 24
The approval is for patients with BCG-unresponsive non-muscle invasive bladder cancer presenting carcinoma in situ, irrespective of papillary…
17 Apr 24
Manufactured by Alvotech, Selarsdi is the second biosimilar approved under the strategic partnership between Alvotech and Teva, for…
04 Apr 24
The approval for Zevtera was based on the clinical efficacy and safety data from the Phase 3 ERADICATE…
28 Mar 24
The approval is supported by the safety and efficacy data from the INNO2VATE programme and post-marketing safety data…
27 Mar 24
The FDA approval, following the US FDA Breakthrough Therapy Designation, is based on the results from the Phase…
25 Mar 24
The FDA approval of Opsynvi, a combination of two proven treatments with established efficacy and safety profiles into…