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May 16, 2025
On 16 May 2025, Bristol Myers Squibb announced that the European Commission (EC) has approved the perioperative regimen of neoadjuvant Opdivo® (nivolumab) and chemotherapy followed by…
May 15, 2025
On 15 May 2025, Regeneron announced that a jury of the US District Court for the District of Delaware found that Amgen had breached antitrust and tort laws by using cross-therapeutic…
May 14, 2025
On 14 May 2025, Sanofi announced that Singapore’s Health Sciences Authority (HSA) has approved Dupixent® (dupilumab) for adults as an add-on maintenance treatment for uncontrolled chronic…
May 12, 2025
On 12 May 2025, the Canadian Federal Court published a decision (issued on 28 April 2025 on a confidential basis) granting Alexion an injunction preventing the Canadian launch of Amgen’s Bkemv®, biosimilar to Alexion’s Soliris® (eculizumab), until 15 March 2027…
May 9, 2025
On 9 May 2025, New Zealand’s drug funding body, Pharmac, announced that it will be widening access to treatments for melanoma from 1 June 2025, including funding MSD’s Keytruda® (pembrolizumab)…
May 9, 2025
On 9 May 2025, Bayer announced that it has submitted a marketing authorisation application to the Ministry of Health, Labour and Welfare in Japan for Eylea™/aflibercept 8mg for treating patients…
May 8, 2025
On 8 May 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved an indication extension for Enhertu® (trastuzumab deruxtecan) in 100 mg…
May 7, 2025
On 7 May 2025, Johnson & Johnson announced that the European Commission (EC) has approved Tremfya® (guselkumab) for the treatment of adults with moderately to severely active Crohn’s disease…
May 6, 2025
On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line…
May 5, 2025
On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab). This includes the addition of…
May 5, 2025
On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations…
May 1, 2025
On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of…
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