IPP Bureau

FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus
FDA reviews AstraZeneca’s Saphnelo for subcutaneous use in Lupus

By IPP Bureau - February 05, 2026

A final decision on the updated application is expected in the first half of 2026, while intravenous (IV) Saphnelo remains commercially available

GPT Healthcare reports 12% revenue growth in 9M FY26, strengthens clinical capabilities
GPT Healthcare reports 12% revenue growth in 9M FY26, strengthens clinical capabilities

By IPP Bureau - February 04, 2026

The company maintained a competitive ARPOB while steadily improving occupancy, driven by higher patient volumes and efficient capacity utilization

Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease
Sanofi’s Venglustat shows breakthrough results in rare neurological Gaucher disease

By IPP Bureau - February 04, 2026

Venglustat, a glucosylceramide synthase inhibitor (GCSi), works by reducing the abnormal buildup of sugar-and-fat molecules in cells and organs

FDA launches PreCheck program to bring drug manufacturing back to US
FDA launches PreCheck program to bring drug manufacturing back to US

By IPP Bureau - February 04, 2026

The program seeks to boost regulatory predictability, support construction of US-based manufacturing sites

Richter’s FYLREVY to transform menopause care in Europe?
Richter’s FYLREVY to transform menopause care in Europe?

By IPP Bureau - February 04, 2026

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

ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer
ALX Oncology’s evorpacept shows promise in HER2-positive breast cancer

By IPP Bureau - February 04, 2026

The findings, based on an exploratory analysis, indicate that CD47 expression may predict which patients benefit most from the therapy

Siemens Healthineers launches €10 million R&D hub in Swords, Ireland
Siemens Healthineers launches €10 million R&D hub in Swords, Ireland

By IPP Bureau - February 04, 2026

The facility is dedicated to breakthrough innovations in laboratory instruments that detect infectious diseases, cancer, and blood disorders

Arctic Vision expands global reach with acquisition of MDCO Technology’s ophthalmic device business
Arctic Vision expands global reach with acquisition of MDCO Technology’s ophthalmic device business

By IPP Bureau - February 04, 2026

Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy
Onchilles Pharma gets FDA green light for first-in-human trials of breakthrough cancer therapy

By IPP Bureau - February 04, 2026

N17350 is the company’s first-in-class tumor-directed therapeutic, designed to harness the ELANE pathway

Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial
Pfizer’s monthly obesity drug shows breakthrough weight loss in Phase 2b trial

By IPP Bureau - February 04, 2026

The study tested whether PF’3944 could maintain efficacy when switching from weekly to monthly injections and remain safe and well-tolerated

Cirena launches to revolutionize long RNA production for CRISPR & gene editing
Cirena launches to revolutionize long RNA production for CRISPR & gene editing

By IPP Bureau - February 04, 2026

As CRISPR and prime editing applications advance, researchers increasingly rely on longer guide RNAs to boost editing efficiency and reduce off-target effects

Epigenica launches EpiFinder Analysis Service to accelerate Epigenomic research
Epigenica launches EpiFinder Analysis Service to accelerate Epigenomic research

By IPP Bureau - February 04, 2026

The new service delivers end-to-end support, managing every stage of an epigenomics project

China nod to Darolutamide for metastatic hormone-sensitive prostate cancer
China nod to Darolutamide for metastatic hormone-sensitive prostate cancer

By IPP Bureau - February 04, 2026

The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT

India’s silent oral cancer crisis: Early detection could save thousands
India’s silent oral cancer crisis: Early detection could save thousands

By IPP Bureau - February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval
SPARC announces receipt of priority review voucher associated with Sezaby approval

By IPP Bureau - February 04, 2026

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases

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