News about Regulation

Sanofi and Regeneron's Dupixent Receives Positive CHMP Opinion

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Dupixent (dupilumab), jointly developed by Sanofi and Regeneron, for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents in the EU.

Regulation | 22/09/2025 | By Dineshwori |  503

PMO Steps In to Support Pharma MSMEs Facing Regulatory-Driven Crisis

The Prime Minister’s Office (PMO) has directed the Ministry of Micro, Small & Medium Enterprises to take urgent action after pharma MSMEs sounded an alarm over regulatory pressures affecting quality control compliance.

Regulation | 19/09/2025 | By Darshana |  314

NPPA Extends Price Cap on Orthopaedic Knee Implants Until November 15, 2025

The National Pharmaceutical Pricing Authority (NPPA) has extended the ceiling price on orthopaedic knee implants for knee replacement systems by two months, pushing the deadline to 15 November 2025. The ceiling price, originally imposed in August 2017 in public interest, had been extended periodically, most recently up to 15 September 2025.

Regulation | 18/09/2025 | By Darshana |  2926

European Commission approves EYLUXVI (ALT-L9) by Alteogen

EYLUXVI is the second biosimilar approved by the European Commission for Alteogen, following the launch of the Herceptin biosimilar in China through its partner Qilu Pharmaceutical.

Regulation | 18/09/2025 | By Dineshwori |  242

IceCure Gets Regulatory Approval in Israel for XSense Cryoablation System

XSense is now approved in Israel for all indications for which ProSense has already received approval in Israel, including general surgery, dermatology neurology, including cryoanalgesia, thoracic surgery, ENT (Ear, Nose, Throat), gynaecology, oncology (including benign and malignant breast tumors), proctology and urology.

Regulation | 17/09/2025 | By Dineshwori |  218

India Revokes Patent for Novartis Cardiac Drug Vymada, Opens Door for Generics

The Indian Patent Office (IPO) has revoked the patent for Novartis’ cardiac drug Vymada—known globally as Entresto—on the grounds of lack of novelty and inventive step.

Regulation | 16/09/2025 | By Darshana |  626

FDA Warns Pharma Companies to Remove Misleading Ads, Issues 100 Cease-and-Desist Notices

The US Food and Drug Administration (FDA) has launched a sweeping crackdown on misleading pharmaceutical advertising, sending thousands of warning letters and issuing about 100 cease-and-desist notices to drugmakers.

Regulation | 13/09/2025 | By Dineshwori |  344

AstraZeneca India Gets NPPA Show-Cause Notice Over Alleged Overcharging of Symbicort Turbuhaler

AstraZeneca Pharma India has received a show cause notice from the National Pharmaceutical Pricing Authority (NPPA) for allegedly overcharging on its Symbicort Turbuhaler Inhalation Powder (60 doses).

Regulation | 12/09/2025 | By Dineshwori |  290

CDSCO Invites Recommendations on Braille Labelling and QR Code Features for Medicine Packaging

The Central Drugs Standard Control Organization (CDSCO) has begun discussions on mandating Braille labelling on medicine strips to help visually impaired individuals identify medicines and read key details like expiry dates.

Regulation | 10/09/2025 | By Dineshwori |  696

FDA Launches 'Green List' to Crack Down on Illegal GLP-1 API Imports

The US Food and Drug Administration (FDA) has created a new “green list” import alert to stop potentially dangerous GLP-1 (glucagon-like peptide-1) active pharmaceutical ingredients (APIs) from unverified foreign sources from entering the US market.

Regulation | 09/09/2025 | By Dineshwori |  1155