US FDA Approves Novartis' Cosentyx for Adolescents with Moderate-to-Severe Hidradenitis Suppurativa
The FDA has approved Novartis’ Cosentyx for patients aged 12 years and above with moderate-to-severe Hidradenitis Suppurativa (HS), marking the therapy’s fourth paediatric indication and expanding treatment options with a differentiated IL-17A mechanism.
US FDA Approves Zydus' Cevimeline Hydrochloride Capsules 30 mg
Zydus Lifesciences has received USFDA approval for Cevimeline Hydrochloride Capsules 30 mg for treating dry mouth associated with Sjögren’s syndrome. The capsules will be manufactured at the company’s SEZ-II facility in Ahmedabad.
India’s drug regulator Central Drugs Standard Control Organisation warns pharmaceutical firms against direct or indirect promotion of prescription-only GLP-1 drugs for obesity, stressing strict compliance with the Drugs and Cosmetics Act, 1940.
Symbiosis Pharmaceutical Services Appoints Joanne Anderson as Chief Commercial Officer
Symbiosis Pharmaceutical Services has appointed Joanne Anderson as CCO, tasking her with leading global commercial strategy as the CDMO expands capacity and strengthens presence across North America and Europe.
Qiagen N.V. has secured U.S. Food and Drug Administration clearance for QIAstat-Dx GI Panels on its QIAstat-Dx Rise system, enabling laboratories to run respiratory and gastrointestinal syndromic tests on a single automated platform.
Roche Pharma India partners with the Government of Punjab to launch NeuroSakhi, a patient support and awareness programme aimed at improving diagnosis, care pathways and treatment access for women with multiple sclerosis.
Chiesi Group Expands Partnership with Bespak to Scale Up Low-Carbon Inhaler Manufacturing
Chiesi Group and Bespak have expanded their partnership to boost pMDI manufacturing capacity in the UK, supporting the rollout of next-generation Carbon Minimal Inhalers designed to significantly reduce environmental impact.
MHRA Clears Deuruxolitinib (Leqselvi) by Sun Pharma for Severe Alopecia Areata in Adults
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved deuruxolitinib (Leqselvi) for treating severe Alopecia Areata in adults, granting authorisation to Sun Pharma UK via the International Recognition Procedure (IRP).
Earendil Labs and WuXi Biologics Partner on Bispecific Antibodies and ADCs
Under the agreement, WuXi Biologics will provide end-to-end development and manufacturing services to Earendil Labs, supporting faster regulatory timelines, reliable CMC execution, and scalable global clinical development.
Veristat Expands Global Regulatory And Clinical Trial Support For Pharma Companies
Veristat, a global clinical research organization (CRO) and regulatory consultancy, has expanded its regulatory and clinical trial support services to help international pharmaceutical and medical device companies navigate approvals in key global markets, including the United Kingdom, Switzerland, Australia, Canada and the United States.
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