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Takeda announced it received approval for EOHILIA ® (budesonide oral suspension) for children aged 11 and older with eosinophilic esophagitis (EoE).  Notably, Dupixent® (dupilumab) was approved to treat children with EoE aged 12 and older in May 2022.  

On 12 February 2024, SMC published that it has approved Novartis’s Cosentyx® (secukinumab) for treatment of active moderate to severe HS, also known as acne inversa, in those adults who have previously had an inadequate response or lost response to conventional systemic ada...

On 12 February 2024, MSD, announced that Health Canada approved its KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy on 6 February 2024. The product is approved as a first-line treatment for patients with advanced positive gastric or gastroesophage...

On 12 February 2024, Biogen announced that the European Commission approved its SKYCLARYS® (omaveloxolone) on 9 February 2024.  SKYCLARYS® was approved for treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older.  The announcement states that...

On 9 February 2024, Biocon Biologics (Biocon) announced that it has signed a five-year exclusive partnership agreement with Sandoz AG. The agreement provides Sandoz AG the right to promote, sell and distribute Biocon’s OGIVRI® (trastuzumab biosimilar) and ABEVMY® (bevacizum...

A study sponsored by Mabwell (Shanghai) Bioscience Co Ltd and published in JAMA Oncology reports that the results of Chinese randomized, 53-week, phase III trials of Mabwell’s MW032 with Amgen’s Xgeva® in patients with solid tumor-related bone metastases, confirm biosimilar...

A Sanofi and Regeneron study published on 11 December 2023 found that dupilumab (compared to placebo) significantly improved lung function in children with uncontrolled asthma. The study was randomised with subjects aged between 6-12 years, and the results showed that by we...

On 7 February 2024, global contract development and manufacturing company Samsung Biologics announced that it has partnered with LegoChem Biosciences for antibody-drug conjugate (ADC) development and manufacturing.  Under the agreement, Samsung Biologics will provide antibo...

On 7 February 2024, the Korea IT Times reported that Celltrion announced that it has won the Norwegian government’s tender to supply Remsima SC® (infliximab biosimilar) and Yuflyma® (adalimumab biosimilar) until 2026.  

Celltrion aims to expand further into the...

On 7 February 2024, Bristol Myers Squibb (BMS) announced the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to II...