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 RastogiSeptember 16, 2026

NEWS

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 RastogiSeptember 16, 2026

NEWS

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 RastogiSeptember 15, 2026

NEWS

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 RastogiSeptember 15, 2026

NEWS

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 RastogiSeptember 15, 2026

NEWS

Cyllene Therapeutics Secures US FDA RMAT Designation for EG110A in Neurogenic Detrusor Overactivity

Shots: The US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to EG110A to treat neurogenic detrusor overactivity (NDO) with urinary incontinence The designation was based on the initial P-Ib/IIa trial data, ongoing in the US, in pts with NDO associated with spinal cord injury, with interim results to be presented at the ICS…

ByRidhi RastogiSeptember 14, 2026

NEWS

Pharming Reports the US FDA Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome

Shots: The US FDA has approved Joenja (leniolisib; 40 & 50mg, BID, PO) for the treatment of children (4-11yrs.; ≥27kg) with activated phosphoinositide 3-kinase delta (APKD) syndrome Approval was backed by a P-III trial in APKD pediatric pts (4-11yrs.), which showed reduced lymphadenopathy & increased naïve B cells over 12wks. with a favorable safety profile…

ByRidhi RastogiSeptember 14, 2026

NEWS

Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Shots: The US FDA has granted Orphan Drug Designation (ODD) to asedebart (Lu AG13909) for the treatment of endogenous Cushing's syndrome Lundbeck is evaluating efficacy and safety of asedebart in proof-of-concept trials for Cushing's disease & classic congenital adrenal hyperplasia (CAH) Asedebart is a humanized anti-ACTH monoclonal antibody that blocks ACTH signaling at the adrenal…

ByRidhi RastogiSeptember 11, 2026

NEWS

Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Shots: The US FDA has granted IND clearance to initiate P-I trial of PRT13722 in HR+/HER2− breast cancer, with patient enrollment expected to begin in Q4’26 The P-I study will assess PRT13722’s safety, tolerability, PK, PD & antitumor activity as monotx. & in combination with endocrine or targeted therapies in adults with locally advanced/metastatic HR+/HER2−…

ByRidhi RastogiSeptember 11, 2026

NEWS

Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Shots: Japan’s MHLW has approved Shingrix in a PFS format (Recombinant Zoster Vaccine or RSV) for the prevention of shingles (herpes zoster) Approval was based on technical comparability between the PFS & existing vaccine presentation; the new presentation does not involve a change in indication or dosing Shingrix combines glycoprotein E with the AS01B…

ByRidhi RastogiSeptember 10, 2026

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

Cyllene Therapeutics Secures US FDA RMAT Designation for EG110A in Neurogenic Detrusor Overactivity

Pharming Reports the US FDA Approval of Joenja (Leniolisib) for Activated Phosphoinositide 3-Kinase Delta Syndrome

Lundbeck’s Asedebart Receives the US FDA Orphan Drug Designation for Endogenous Cushing’s Syndrome

Prelude Therapeutics Receives FDA IND Clearance for PRT13722

Japan’s MHLW Approves GSK’s Shingrix PFS Presentation to Protect Individuals Against Shingles

Contact US

FOLLOW US