News about Regulation

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 |  201

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 |  155

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 |  567

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 |  277

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 |  251

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 |  656

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 |  1099

Alembic Pharmaceuticals Secures USFDA Final Approval for Phytonadione Injectable Emulsion

Alembic Pharmaceuticals has received final USFDA approval for its Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, used in treating and preventing vitamin K deficiency-related conditions.

Regulation | 09/09/2025 | By Mrinmoy Dey |  286

India's drug regulator to ease oversight and deploy AI for greater efficiency

India’s drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is preparing to introduce fixed timelines for drug approvals and increase the use of artificial intelligence to strengthen efficiency and transparency.

Regulation | 05/09/2025 | By Darshana |  568

Drug and Device Manufacturers Must Value Promotional Samples at Market Entry Price, Government Clarifies

The Indian government has issued a clarification under the Uniform Code for Pharmaceutical Marketing Practices, mandating that drug and medical device manufacturers must value free promotional samples using the same price charged to the stockist or immediate customer.

Regulation | 04/09/2025 | By Darshana |  250