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Bayer presents Phase III VICTOR clinical trial data of vericiguat at ESC Congress 2025
News | August 31, 2025

Bayer presents Phase III VICTOR clinical trial data of vericiguat at ESC Congress 2025

The positive benefit-risk profile of vericiguat in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase III VICTORIA trial remains unchanged


Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide
News | August 31, 2025

Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide

The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users


Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran
News | August 31, 2025

Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran

Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives


MHRA approves UK’s first new type of antibiotic for urinary tract infections
News | August 30, 2025

MHRA approves UK’s first new type of antibiotic for urinary tract infections

As with any medicine, the MHRA will keep the safety of gepotidacin under close review


Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial
News | August 29, 2025

Lilly's oral GLP-1 orforglipron succeeds in Phase 3 trial

Triggering global regulatory submissions this year for the treatment of obesity


Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2
Drug Approval | August 29, 2025

Moderna receives FDA approval for updated COVID-19 vaccines for LP.8.1 Variant of SARS-CoV-2

The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age


Thermo Fisher opens pipette manufacturing site in North Carolina
News | August 28, 2025

Thermo Fisher opens pipette manufacturing site in North Carolina

New manufacturing facility in Mebane to produce at least 40 million laboratory pipette tips per week


FDA approves Coya Therapeutics’ trial of COYA 302 for ALS
News | August 28, 2025

FDA approves Coya Therapeutics’ trial of COYA 302 for ALS

As part of its partnership with Dr. Reddy’s Laboratories (DRL), FDA acceptance also triggers a $4.2 million milestone payment to Coya