The recent STELARA FDA approval provides a crucial new non-TNF biologic treatment option for children two years and older suffering from moderately to severely active Crohn’s disease.
Merck receives Idvynso FDA approval for its once-daily single-tablet regimen of doravirine and islatravir. This breakthrough treatment offers a new option for adults living with HIV-1 who are virologically suppressed.
Sanofi has achieved a historic breakthrough with the expanded Tzield FDA approval for young children. Previously restricted to those aged eight and older, the therapy is now available for children as young as one year old, offering a vital window to delay the onset of clinical Type 1 Diabetes.
Indian health officials have intercepted a shipment of suspected counterfeit weight-loss medication. The discovery of fake Mounjaro pens underscores a growing global trend of illicit medical supplies entering the market through online platforms like Alibaba.
Pfizer and Merck announce that the FDA has accepted a supplemental Biologics License Application (sBLA) for PADCEV in combination with KEYTRUDA for Priority Review in patients with muscle-invasive bladder cancer (MIBC).
GSK has reached a major milestone with the NMPA’s Exdensur depemokimab China approval. This ultra-long-acting biologic offers a breakthrough for severe asthma patients, requiring only two doses per year to maintain symptom control.
Eli Lilly has officially received Foundayo FDA approval for orforglipron, the first daily non-peptide oral GLP-1 receptor agonist that offers significant weight loss results without the dietary restrictions of previous oral treatments.
GSK has secured the Exdensur depemokimab China approval from the NMPA, introducing the first respiratory biologic with a twice-yearly dosing regimen for patients with severe eosinophilic asthma.
GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data from the ARTEMIS-001 trial, this B7-H3-targeted antibody-drug conjugate aims to transform the prognosis for patients with extensive-stage disease, who currently face a median survival of just 8 months. This marks the sixth major global regulatory designation for risvutatug rezetecan, signaling its critical role in the future of oncology.
ohnson & Johnson has announced FDA approval of ICOTYDE (icotrokinra), the first and only IL-23R targeted oral peptide designed for first-line systemic treatment of moderate-to-severe plaque psoriasis. This groundbreaking approval represents a paradigm shift in dermatology, offering patients unprecedented efficacy with complete skin clearance in over 70% of clinical trial participants.
