Pharma Exclusives Pressreleases
Roche provides regulatory update on Elevidys™ gene therapy for Duchenne muscular dystrophy in the EU
Friday, July 25, 2025Rocheannounced today that the Committee for Medicinal Products for Human Use CHMP of the European Medicines Agency EMA issued a negative opinion on the conditional marketing authorisation CMA for Elevidys
Roche receives CE Mark for minimally invasive blood test to help rule out Alzheimer’s disease
Wednesday, July 23, 2025Roche announced today it has received CE Mark for its Elecsys pTau test to measure phosphorylated Tau pTau protein which is an indicator of amyloid pathology a hallmark of Alzheimers disease
European Commission approves Roche’s Itovebi for people with ER-positive, HER2-negative, advanced breast cancer with a PIK3CA mutation
Wednesday, July 23, 2025Rocheannounced today that the European Commission has approved Itovebi inavolisib in combination with palbociclib Ibrance and fulvestrant for the treatment of adult patients with PIKCAmutated oestrogen receptor
Roche provides update on astegolimab in chronic obstructive pulmonary disease
Monday, July 21, 2025Rocheannounced today topline results from the pivotal phase IIb ALIENTO n and the phase III ARNASA n trials investigating astegolimab compared to placebo on top of standard of care maintenance therapy
Cybin Receives UK MHRA Approval to Commence EMBRACE, A Multinational Pivotal Study Evaluating CYB003 for the Adjunctive Treatment of Major Depressive Disorder
Thursday, July 17, 2025Cybin Inc a clinicalstage breakthrough neuropsychiatry company committed to advancing mental healthcare by developing new and innovative nextgeneration treatment options today announced that it has received approval
U.S. FDA Approves Finerenone for New Indication in Patients with Heart Failure with Left Ventricular Ejection Fraction of 40%
Monday, July 14, 2025Finerenone is the first drug targeting the mineralocorticoid receptor MR pathway to demonstrate statistically significant and clinically meaningful cardiovascular benefits in a Phase III study in adult patients with heart failure
Boehringer Ingelheim and LEO Pharma enter partnership to commercialize and further develop SPEVIGO® (spesolimab)
Monday, July 14, 2025Boehringer Ingelheim and LEO Pharma today announced an exclusive global license and transfer agreement to commercialize and advance the development of SPEVIGO spesolimab
Bayer receives first approval worldwide for Lynkuet™ (elinzanetant) in the UK as treatment of moderate to severe vasomotor symptoms associated with menopause
Friday, July 11, 2025Bayer today announced that the Medicines and Healthcare products Regulatory Agency MHRA regulatory authority in the UK has authorized the use of elinzanetant the first dual neurokinin NKtargeted therapy
Bayer files for EU approval of gadoquatrane
Thursday, July 10, 2025Bayer today announced the submission of a marketing authorization application to the European Medicines Agency for its investigational contrast agent gadoquatrane for contrast enhancement in magnetic resonance imaging
Hongene Supports Clinical Advancement of siRNA DNV001 Using Proprietary Chemoenzymatic Ligation Platform
Thursday, July 10, 2025Hongene Biotech Corporation a contract development and manufacturing organization CDMO specializing in nucleic acid therapeutics today announced its critical role in advancing DNV
