The US Food and Drug Administration (FDA) has approved Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar referencing Lucentis (ranibizumab).
21 Sep 2021
17 Sep 2021
Health Canada has granted full approval to Moderna’s Spikevax and Pfizer-BioNTech’s Comirnaty Covid-19 vaccines for use in individuals aged 12 years and above.
07 Sep 2021
The European Medicines Agency (EMA) has started evaluation of the data on a booster (third) dose for the Covid-19 vaccine, Comirnaty, developed by Pfizer and BioNTech.
01 Sep 2021
Teva Pharmaceuticals and MedinCell’s new drug application (NDA) for their drug, TV-46000/mdc-IRM to treat schizophrenia has been accepted by the US Food and Drug Administration (FDA).
31 Aug 2021
The US Food and Drug Administration (FDA) has approved an expanded indication for UCB’s Briviact (brivaracetam) CV as monotherapy or adjunctive therapy for the treatment of partial-onset seizures in paediatric patients aged one month and above.
27 Aug 2021
Forxiga, a SGLT2 inhibitor, is the first medicine to secure approval for the treatment of CKD in Japan.
26 Aug 2021
Pfizer and its partner BioNTech are seeking approval from the US Food and Drug Administration (FDA) for their booster dose of Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.
25 Aug 2021
The European Commission (EC) has approved AbbVie's Rinvoq (upadacitinib) to treat moderate to severe atopic dermatitis in adults and adolescents aged 12 years and above who are candidates for systemic therapy.
24 Aug 2021
The US Food and Drug Administration (FDA) has fully approved Pfizer and BioNTech’s biologics license application (BLA) for their Covid-19 vaccine, Comirnaty, for individuals aged 16 years and above.
23 Aug 2021
The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Zydus Cadila’s ZyCoV-D Covid-19 vaccine for adolescents aged 12 years and above.