The US Food and Drug Administration (FDA) has approved Galderma’s Nemluvio (nemolizumab) as a pre-filled pen for subcutaneous injection for the treatment of adults with prurigo nodularis. 14 August 2024
A commercial stage biopharmaceutical R&D company, focused on the development of products that address the medical challenges in the therapeutic area of anti-infectives.
Australian dermatology company Botanix today revealed it has received a communication from the US Food and Drug Administration (FDA) in relation to its New Drug Application (NDA) submission for sofpironium bromide (SB) gel, 15%. 26 September 2023
Privately-held Danish company MC2 Therapeutics has acquired option rights from US dermatology firm Regranion to exclusively license the latter’s RGRN-305 for the treatment of all human diseases. 25 September 2023
Belgian drugmaker UCB is not expecting a decision from the US Food and Drug Administration (FDA) any time soon on its Biologics License Application (BLA) for Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis. 20 September 2023
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorization for Adtralza (tralokinumab) in a new pre-filled pen, developed by privately-held Danish dermatology specialist LEO Pharma. 20 September 2023
The European Commission (EC) has become the third medicines regulator to grant marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata. 19 September 2023
Citing resource constraints for the decision, the US Food and Drug Administration (FDA) says requires additional time to complete the Priority Review of Iovance Biotherapies’ Biologics License Application (BLA) for lifileucel. 18 September 2023
Following its September 2023 meeting, the European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended approval of six novel medicines. 15 September 2023
Samsung Bioepis has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Johnson & Johnson subsidiary Janssen’s Stelara (ustekinumab). 11 September 2023
Industry analyst GlobalData has released research suggesting that a new Humira (adalimumab) biosimilar can expect to reach over $800 million in sales by the end of the decade. 1 September 2023
Danish dermatology focused LEO Pharma has announced the launch of Anzupgo (delgocitinib) cream in Germany for the treatment of adult patients with moderate to severe chronic hand eczema (CHE), for whom topical corticosteroids are inadequate or inappropriate. 15 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024