News and Updates about the regulations in Drugs and Pharma
Sequana Medical NV, at the forefront of addressing fluid overload in liver disease, heart failure, and cancer, has unveiled a newly published study in the esteemed Kidney Medicine journal. The publication reviews the company’s innovative DSR 2.0 technology featured in […]
**Study Indicates No Negative Neurological Impact on Kids from Moms Using Certain Epilepsy Drugs During Pregnancy** An ongoing study financed by the National Institutes of Health (NIH) has found that children of mothers who took specific anti-seizure medications during pregnancy
BioArctic AB’s (publ) associate, Eisai, has rolled out Leqembi (generic name: lecanemab) in South Korea. This comes after the medication was greenlit in May 2024, for adults exhibiting mild cognitive impairment due to Alzheimer’s disease (AD) or early-stage AD dementia.
Eisai Introduces Leqembi in South Korea for MCI and Mild Alzheimer’s Treatment Read More »
Innovent Biologics, Inc., a premier biopharmaceutical enterprise focused on the development, production, and distribution of top-tier medications for oncology, cardiovascular, autoimmune, ophthalmology, and other significant health conditions, has announced that the 2024 National Reimbursement Drug List (NRDL) will now feature
BIO INX, recognized for its cutting-edge bioinks in the realm of 3D bioprinting, has teamed up with Carl Roth, a renowned entity in the domain of research chemicals and laboratory equipment, entering a new distribution agreement. This strategic partnership represents
BIO INX Joins Forces with Carl Roth to Enhance Global 3D Bioprinting Accessibility Read More »
On November 27, 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted approval for flortaucipir (Tauvid), a radiopharmaceutical formulation, intended for adults experiencing memory concerns. This enables doctors to conduct PET (Positron Emission Tomography) brain scans. Utilized in conjunction
UK Authorizes Flortaucipir Diagnostic Tool for Alzheimer’s Cognitive Symptoms Read More »
Lin BioScience, a biopharmaceutical company advancing clinical-stage drug development for novel treatments in acute leukemia with significant unmet needs, has announced that its lead candidate, LBS-007, has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) to
Lin BioScience’s LBS-007 Gains FDA Fast Track Status for Acute Leukemia Therapies Read More »
GlaxoSmithKline (GSK) plc has reported that the European Commission (EC) has given its approval for a new, single-vial liquid version of Menveo, a Meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY vaccine). This innovation provides protection against invasive
European Regulators Green-light GSK’s Liquid Menveo MenACWY Vaccine Read More »
Akeso, Inc., a prominent company in the biopharmaceutical sector, has revealed that its two pioneering bispecific antibody drugs—cadonilimab (a PD-1/CTLA-4 bispecific antibody) and ivonescimab (a PD-1/VEGF bispecific antibody)—have been added to the latest edition of the National Reimbursement Drug List
Akeso’s Cadonilimab and Ivonescimab Listed in China’s NRDL Read More »
Formosa Pharmaceuticals, based in Taiwan, has successfully secured an exclusive licensing deal with Switzerland’s Medvisis Switzerland AG for the rights to market the innovative clobetasol propionate ophthalmic suspension, 0.05% (APP13007), in Switzerland and Liechtenstein. This formulation is designed to treat