Drugs

News and Updates about the regulations in Drugs and Pharma

EMA’s Human Medicine Committee Supports Approval of Acoramidis in Treating Transthyretin Amyloid Cardiomyopathy

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has endorsed acoramidis for market authorization in the European Union. Acoramidis is an orally consumed, selective small-molecule stabilizer of transthyretin (TTR). It targets adult individuals diagnosed with […]

EMA’s Human Medicine Committee Supports Approval of Acoramidis in Treating Transthyretin Amyloid Cardiomyopathy Read More »

FDA Grants Breakthrough Status to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive MS

The U.S. Food and Drug Administration has awarded Breakthrough Therapy status to tolebrutinib for treating adult patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This decision stems from promising results in the HERCULES phase 3 trial, where tolebrutinib showed a

FDA Grants Breakthrough Status to Sanofi’s Tolebrutinib for Non-Relapsing Secondary Progressive MS Read More »

EMA Advocates EU Marketing Authorisation for Emcitate by Rare Thyroid Therapeutics for Peripheral Thyrotoxicosis in AHDS Patients

The European Medicines Agency (EMA) has given its nod for marketing authorisation within the European Union (EU) for Emcitate (tiratricol), designed as an oral therapy targeting peripheral thyrotoxicosis, characterized by abnormal elevations of circulating thyroid hormones within individuals suffering from

EMA Advocates EU Marketing Authorisation for Emcitate by Rare Thyroid Therapeutics for Peripheral Thyrotoxicosis in AHDS Patients Read More »

Merck Receives Favorable EU CHMP Verdict for Welireg in Certain VHL Tumors and Advanced RCC Patients After Prior Treatments

Merck, operating as MSD outside the US and Canada, revealed that the European Medicines Agency’s CHMP recommended conditionally approving Welireg (belzutifan), an oral inhibitor targeting hypoxia-inducible factor-2 alpha (HIF-2a), as a standalone treatment for: Adults with von Hippel-Lindau (VHL) disease

Merck Receives Favorable EU CHMP Verdict for Welireg in Certain VHL Tumors and Advanced RCC Patients After Prior Treatments Read More »

Firm Measures Announced for Controlling Non-Prescription Drug Sales: Tamil Nadu’s New Drug Controller

M Sridhar, the incoming director of the Tamil Nadu Drug Control Administration (DCA), has announced plans to severely restrict the sale of habit-forming drugs and abortion pills without a prescription. Offenders will face stringent consequences. District-level awareness campaigns, headed by

Firm Measures Announced for Controlling Non-Prescription Drug Sales: Tamil Nadu’s New Drug Controller Read More »

DoP’s Strategic Policy Efforts Strengthen State-Funded Nagalpar Park in Gujarat: Insights from Dr H G Koshia

The Department of Pharmaceuticals (DoP) is significantly impacting India’s medical device manufacturing landscape by implementing targeted programs and financial backing for state-driven projects. Dr H G Koshia, Commissioner of the Gujarat Food and Drug Control Administration (FDCA), highlights that Gujarat’s

DoP’s Strategic Policy Efforts Strengthen State-Funded Nagalpar Park in Gujarat: Insights from Dr H G Koshia Read More »

Dr. Prabhu Vinayagam: Enhancing Drug Development and Infection Control is Crucial for Combating AMR in India

India must focus on innovative drug development, vaccine enhancement, and improving infection control strategies to effectively counter antimicrobial resistance (AMR). From both national and global perspectives, recent advancements in AMR treatment include bacteriophage therapy, nanotechnology, and immunotherapies, among others. According

Dr. Prabhu Vinayagam: Enhancing Drug Development and Infection Control is Crucial for Combating AMR in India Read More »