FDA

During October, the Central Drugs Standard Control Organisation (CDSCO) assessed drug samples across various laboratories and found 56 samples from central labs and 24 from state-regulated labs to be Not of Standard Quality (NSQ). Additionally, three drug samples collected by […]

**Lupin Secures Tentative Green Light from US FDA for Generic Janumet Tablets** Lupin Limited, a prominent player in the global pharmaceutical sector, recently shared news of its tentative approval from the United States Food and Drug Administration (FDA). This nod

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.

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

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

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

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