Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 3

Results For "marketing-authorization"

202 News Found

Zuellig Pharma expands Cialis footprint across Asia
News | March 16, 2026

Zuellig Pharma expands Cialis footprint across Asia

The expanded ownership is expected to improve access to Cialis for millions of men in Asia affected by ED and BPH


Veristat expands global trial & regulatory services as Chinese drugmakers push overseas
Clinical Trials | March 14, 2026

Veristat expands global trial & regulatory services as Chinese drugmakers push overseas

The expansion builds on Veristat’s work helping Chinese pharmaceutical firms such as Hansoh Pharma and CStone Pharmaceuticals


Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease
News | March 10, 2026

Sumitomo Pharma bags world-first go-ahead for iPS cell therapy to treat Parkinson’s disease

The conditional, time-limited approval comes through a joint effort with RACTHERA, a joint venture in which Sumitomo Chemical holds a 66.6% stake and Sumitomo Pharma holds 33.4%


Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria
Clinical Trials | February 28, 2026

Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria

The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines


ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access
Biotech | February 18, 2026

ExCellThera’s Zemcelpro scores big in Germany, paving way for early hospital access

The therapy, also known as UM171 Cell Therapy, recently received conditional marketing authorization from the European Commission


Moderna’s new Covid vaccine mNEXSPIKE wins European approval
News | February 17, 2026

Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe


STADA & Bio-Thera bag European nod for Gotenfia
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia


Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke
Clinical Trials | February 07, 2026

Bayer’s asundexian demonstrated 26% reduction in stroke after a non-cardioembolic ischemic stroke

These results were consistent across all clinically relevant patient subgroups regardless of key patient characteristics like age or sex, the cause of stroke or the severity of the stroke


Richter’s FYLREVY to transform menopause care in Europe?
News | February 04, 2026

Richter’s FYLREVY to transform menopause care in Europe?

The recommendation covers FYLREVY 14.2 mg and 18.9 mg for non-hysterectomised postmenopausal women experiencing oestrogen deficiency symptoms at least 12 months after their last menses


EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C
News | January 28, 2026

EU green light to IntraBio’s AQNEURSA for rare neurological disease Niemann-Pick Type C

The approval is grounded in data from a Phase III randomized, double-blind, placebo-controlled, crossover study in NPC patients