Zealand Pharma Reports CHMP Positive Opinion for Zeydovio (Glepaglutide) for Short Bowel Syndrome (SBS)

Shots: The CHMP has recommended Zeydovio (glepaglutide) for the treatment of adults with SBS. Zealand is pursuing partnerships for the future global commercialization of Zeydovio for SBS Opinion was based on the P-III (EASE-1) trial of Zeydovio (10mg, QW or Q2W) vs PBO in 106 SBS pts with intestinal failure (IF), dependent on parenteral support…

BySaurabh Chaubey5 hours ago

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The CHMP Recommends Novo’s Frehemgo (Denecimig) for Haemophilia A

Shots: The CHMP has recommended Frehemgo (QM, Q2W or QW) to treat haemophilia A, with or without inhibitors, in adults & children, based on the FRONTIER program; launch is expected in the first EU countries in Q4’26 & broadly across the EU starting early 2027 FRONTIER 2 trial showed Frehemgo significantly reduced annualized bleeding rates…

ByRidhi Rastogi6 hours ago

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Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

Shots: The CHMP has recommended Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for pts with resectable muscle-invasive bladder cancer (MIBC); if approved, authorization would be valid in all 30 EEA states Opinion was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj.…

ByRidhi Rastogi7 hours ago

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The US FDA Approves Ultragenyx’s Fayuvi for Sanfilippo Syndrome Type A

Shots: The FDA has granted full approval to Fayuvi (rebisufligene etisparvovec-hopf) for pediatric pts with Sanfilippo syndrome Type A, plus a Priority Review Voucher; commercial product will be available for shipment to QTCs within 30-60 days Approval was supported by pivotal Transpher A & long-term follow-up data, where Fayuvi-treated pts from the mITT population (n=17)…

ByRidhi Rastogi11 hours ago

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Biogen and Eisai Report MHLW Approval of Leqembi Pen (SC) for Early Alzheimer’s Disease

Shots: The MHLW has approved Leqembi Pen (SC autoinjector) administered as 500mg given QW as two pens, each delivered in ~15secs, for the treatment of early Alzheimer's disease Approval was supported by 18mos. P-III Clarity AD data in pts with mild cognitive impairment (MCI) due to AD or mild AD dementia & multiple SC administration…

ByRidhi Rastogi2 days ago

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Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has approved Vyepti (eptinezumab) for the prevention of migraine attacks in adults Approval was backed by extensive clinical data, incl. P-III (PROMISE-1, PROMISE-2 & DELIVER) studies as well as P-III (SUNRISE) trial, which assessed Vyepti in a predominantly Asian population; NDA was further supported by the SUNSET LTE trial conducted in Japanese…

ByRidhi Rastogi2 days ago

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Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM)

Shots: The US FDA has accepted an NDA for bezuclastinib in pts with AdvSM, plus set a PDUFA target action date of Jun 29, 2027, with no plans to hold an advisory committee, as well as no potential review issues identified NDA was backed by the APEX trial, which showed as of Mar 31, 2026,…

ByRidhi Rastogi2 days ago

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Curium Receives FDA Approval for Bexlutry to Treat GEP-NETs

Shots: The US FDA has approved Bexlutry (lutetium Lu 177 dotatate injection) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), covering foregut, midgut, & hindgut NETs Bexlutry is a radioligand equivalent developed through the 505(b)(2) regulatory pathway, targeting Lutathera. The approval is supported by published evidence & targeted bridging data demonstrating…

ByRidhi Rastogi3 days ago

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Organon Reports the US FDA sNDA Acceptance for Miudella

Shots: The US FDA has accepted the sNDA of Miudella (hormone-free copper intrauterine system) for an extended duration of use for up to 6yrs. with the PDUFA action date expected in Q2’27 Miudella was evaluated in 3 trials across US in 1904 women (17-45yrs.), where the efficacy cohort (17-35yrs.) of the P-III trial (n=1397) showed…

ByRidhi Rastogi3 days ago

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Telix Gains US FDA Approval for Pixclara for Brain Cancer Imaging

Shots: The US FDA has approved Pixclara (floretyrosine F 18) for pts (≥1mos.) as the FET-PET imaging drug for glioma, enabling PET imaging to help differentiate recurrent or progressive glioma from treatment-related changes Pixclara comprises a small-molecule targeting agent & fluorine-18; it binds with LAT1 & LAT2 transporters after IV administration, allowing the radioisotope’s emissions…

ByRidhi Rastogi3 days ago

Zealand Pharma Reports CHMP Positive Opinion for Zeydovio (Glepaglutide) for Short Bowel Syndrome (SBS)

The CHMP Recommends Novo’s Frehemgo (Denecimig) for Haemophilia A

Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

The US FDA Approves Ultragenyx’s Fayuvi for Sanfilippo Syndrome Type A

Biogen and Eisai Report MHLW Approval of Leqembi Pen (SC) for Early Alzheimer’s Disease

Lundbeck Reports the MHLW Approval of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Cogent Biosciences Reports US FDA’s NDA Acceptance of Bezuclastinib for Advanced Systemic Mastocytosis (AdvSM)

Curium Receives FDA Approval for Bexlutry to Treat GEP-NETs

Organon Reports the US FDA sNDA Acceptance for Miudella

Telix Gains US FDA Approval for Pixclara for Brain Cancer Imaging

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