February Biotech PDUFA Pulse:
📡 What’s on the FDA Radar
Feb 8 | $RGNX – RGX-121 (MPS II / Hunter syndrome), Priority Review
Feb 20 | $MRK – Keytruda® (platinum-resistant recurrent ovarian cancer), Priority Review (label expansion)
Feb 21 | $VNDA – Bysanti™ (bipolar I disorder / schizophrenia)
Feb 25 | $ETON – ET-600 (central diabetes insipidus)
Feb 28 | $ASND – TransCon® CNP (achondroplasia), Priority Review
Feb 28 | $BMRN – PALYNZIQ® (PKU, adolescents), Priority Review (label expansion)
See the attached graphic for the full February PDUFA calendar.
Introducing ISCP’s New President — Professor Doreen Su-Yin Tan!
We are delighted to announce that Prof. Doreen Su-Yin (@doreen_syTan) has assumed the role of President of the International Society of Cardiovascular Pharmacotherapy (ISCP) effective January 1, 2026 — marking a historic milestone as our first female President.
Prof. Tan is an Associate Professor in Clinical & Pharmacy Practice at the National University of Singapore and a leading expert in cardiometabolic management, implementation science, pharmacogenomics, and person-centred care models. She also serves in key roles in clinical guidance and national initiatives for cardiology pharmacy practice.
Her leadership reflects ISCP’s commitment to innovation, collaboration, and evidence-based cardiovascular care worldwide. Join us in congratulating Prof. Tan as she guides ISCP into an exciting new chapter.
📷 Learn more about our leadership:
https://t.co/8MFnXt2xuq
#ISCP #ISCPPresident #CardiologyLeadership #CardiovascularPharmacotherapy #ISCP2026
@ALorenzatti@PabloAvanzas@amartinezrubio@KojiHasegawa6@jckaski@kjfilipiak@beaverspharmd@KarleziAlonso@VebionaBachtar@DanielPiskorz@DrPontecarlosi@santon74@kit6750@kfranco_c@JD_Bennetts@Risantilopezcar@jacktanwc
Delighted to see our @escardio Task Force on Allied Professionals paper published.
"A multidisciplinary approach to reduce the burden of cardiovascular disease.."
https://t.co/D5WstV1om1
Fantastic to visit Lansbury Pharmacy and have a rapid lipid test from pharmacist Milad. This is a great initiative to identify people's risk of CVD at community pharmacies across North East London, with specialist clinical support from St Bartholomew’s Hospital @PrimaryCareNHS
'Helping patients get the right treatment for minor illnesses quickly, often without visiting a GP or hospital is what I enjoy most.' — Damisola, Community Pharmacist
This World Pharmacists Day, we're thanking Damisola and all pharmacy teams across England for your hard work 💙
Delighted to be the speaking on the topic of the “Power of Multidisciplinary Teams in Cardiovascular Health” at the World Congress of Cardiology #WCC in partnership with the European Society of Cardiology #ESCongress in Madrid this week.
Well done everyone. Really pleased as to how this has improved patient care with the rapid up-titration of evidence based medicines. #implementationscience
Delighted to be shortlisted @HSJ_Awards 2025 for STaRT-HF: Structured Titration and Rapid Treatment for #HeartFailure across @NHS_NELondon delivering remote monitoring & individualised care, transforming treatment for people living with HF. Couldn't be prouder of the team!
Really pleased to see this published, and glad to have been a co-author alongside such a fantastic team led by @J_Hendriks1 and Lien Desteghe, including @lisneubeck , @santon74 , Geraldine Lee, Jose Merino and Emma Sveenberg
Celebrating the 10th anniversary of Barts Heart Centre, showcasing how pharmacy has developed over the years, from making up medicines to providing ward based and outreaches services with cholesterol testing in community pharmacy. @NHSBartsHealth
This video has made my day- it’s run by Brian Coleman - he is the cement that has built cardiac rehab at whipps probably doesn’t even have an X account he is so unassuming. Programmes like this are so important! https://t.co/GHQgYaQnFK
@TheBHF@mdstbarts@NHSBartsHealth