Axsome Therapeutics’ investigational oral drug AXS-05 is advancing clinical development for Alzheimer’s disease agitation and smoking cessation, leveraging a unique multimodal mechanism targeting key neurotransmitter pathways.
FibroBiologics Files IND Application with US FDA for CYPS317 in Psoriasis
FibroBiologics has filed an Investigational New Drug (IND) application with the US FDA for CYPS317, marking a key step towards initiating clinical development of the therapy for psoriasis, supported by encouraging preclinical data showing reduced disease severity and relapse.
Manoj Joshi Assumes Charge as Secretary, Department of Pharmaceuticals
Senior Indian Administrative Service officer Manoj Joshi has taken charge as the new Secretary of the Department of Pharmaceuticals under the Ministry of Chemicals and Fertilisers, following approval by the Appointments Committee of the Cabinet.
Elanco Secures USDA Approval for Befrena mAb, Strengthening Canine Dermatology Portfolio
Elanco Animal Health Incorporated has received approval from the US Department of Agriculture (USDA) for Befrena (tirnovetmab), marking the company’s entry into the fast-growing canine dermatology segment with an anti-IL-31 monoclonal antibody therapy for allergic and atopic dermatitis in dogs.
Intelligent Bio Solutions Inc (INBS), a medical technology company focused on rapid, non-invasive testing solutions, has entered into a strategic manufacturing partnership with Syrma Johari MedTech Ltd to scale production of its Intelligent Fingerprinting Drug Screening Reader and support long-term margin expansion.
Health Minister Highlights Expansion of Jan Aushadhi Kendras and AMRIT Pharmacies
Union Health Minister JP Nadda underscored the importance of expanding Jan Aushadhi Kendras and AMRIT pharmacies across the country, while emphasising the need for a robust drug regulatory framework that ensures quality, safety and compliance from manufacturing through last-mile distribution.
HUTCHMED Gets Priority Review in China for Fanregratinib NDA
HUTCHMED’s NDA for fanregratinib in second-line intrahepatic cholangiocarcinoma has been accepted in China with priority review status, supported by data from a phase II registration trial addressing a high-unmet-need liver cancer indication.
Health Minister JP Nadda Unveils 10th Indian Pharmacopoeia
The Union Health Minister highlighted the Indian Pharmacopoeia’s recognition in 19 Global South countries, India’s rise to eighth globally in WHO pharmacovigilance, and key updates in IP 2026, including 121 new monographs and the first inclusion of blood component standards.
New Leadership Elected at Telangana State Chemists and Druggists Association
With the start of the new year, the Telangana State Chemists and Druggists Association (TSCDA) has ushered in a new phase of leadership following the completion of its state-level elections. The polls were conducted on Sunday at the TSCDA Bhavan in Hyderabad, with members from across Telangana participating to elect the association’s new office-bearers.
HAI Solutions Secures FDA De Novo Clearance for UVC-Based QIKCAP IV Connector Disinfection System
HAI Solutions, a company focused on ultraviolet (UVC) microbial reduction technologies for healthcare settings, announced that the US Food and Drug Administration (FDA) has granted De Novo classification to its QIKCAP System.
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