News about Regulation

LYNKUET (Elinzanetant) Gets Expanded Canada Approval for Breast Cancer-Related Hot Flashes

LYNKUET (elinzanetant) receives expanded Canadian authorisation to treat moderate to severe hot flashes and night sweats caused by breast cancer Adjuvant Endocrine Therapy (AET).

Regulation | 18/08/2026 | By News Bureau |  261

UK MHRA Approves Vimseltinib for Tenosynovial Giant Cell Tumours

UK MHRA approves Deciphera Pharma’s vimseltinib for adults with tenosynovial giant cell tumours affecting movement or where surgery is not an option.

Regulation | 18/08/2026 | By News Bureau

PM Modi Urges Indian Pharma Firms to Join World's Top 5

Prime Minister (PM) Narendra Modi urges Indian pharma companies to join the world’s top 5, strengthen global competitiveness and build Indian brands as a global identity.

Regulation | 17/08/2026 | By News Bureau

Lupin Announces Approval from US FDA for Pitolisant Tablets

Lupin receives US Food and Drug Administration (FDA) approval for Pitolisant Tablets, 4.45 mg and 17.8 mg, a generic version of Wakix, for indications covered by the approved labeling.

Regulation | 17/08/2026 | By News Bureau |  114

Aurobindo Pharma's Raleigh Plant Receives VAI Classification from US FDA

Aurobindo Pharma’s Raleigh plant receives Voluntary Action Indicated (VAI) classification from the US Food and Drug Administration (FDA), closing the inspection and allowing pending inhaler and dosage-form applications to progress.

Regulation | 17/08/2026 | By News Bureau |  157

Sun Pharma Wins Key US Appeals Court Ruling in Lipitor Antitrust Litigation

Sun Pharma wins a key US appeals court ruling in the Lipitor antitrust case, with summary judgment upheld in favor of the company and its subsidiaries.

Regulation | 17/08/2026 | By News Bureau |  213

US FDA Grants Accelerated Approval to BMS' ZENBEXUS for Multiple Myeloma

The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS) ZENBEXUS, a first-in-class CELMoD therapy combined with daratumumab and dexamethasone for multiple myeloma.

Regulation | 14/08/2026 | By News Bureau |  148

Pfizer and Valneva's Lyme Vaccine Candidate Gets EMA Review Validation

Pfizer and Valneva’s Lyme disease vaccine candidate receives validation from the European Medicines Agency (EMA), supported by more than 70 percent efficacy in the phase 3 VALOR trial.

Regulation | 14/08/2026 | By News Bureau |  106

Aurobindo Pharma's Eugia Unit I Receives US FDA Warning Letter

Aurobindo Pharma’s Eugia Pharma Unit I receives a US Food and Drug Administration (FDA) Warning Letter following OAI status, with no impact on existing US supplies.

Regulation | 14/08/2026 | By News Bureau |  403

China Accepts Bayer's Aflibercept 8 mg Application for RVO Macular Edema Review

China’s National Medical Products Administration (NMPA) accepts aflibercept 8 mg for review in RVO-related macular edema, supported by positive Phase 3 QUASAR results.

Regulation | 14/08/2026 | By News Bureau |  185