Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Shots: The US FDA has granted Fast Track designation to Lu AH69593 for the treatment of patients with narcolepsy Lu AH69593 is a small-molecule orexin 2 receptor agonist being developed by Lundbeck for narcolepsy to regulate arousal, wakefulness, & sleep-wake stability Lu AH69593 is being evaluated in a P-Ib clinical program, with Lundbeck continuing to…

ByRidhi Rastogi10 hours ago

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Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Shots: The NMPA has approved ciprocopan (NXP100, QD, PO) for the treatment of pts with PNH previously untreated with Complement inhibitors. Application for PNH pts previously treated with anti-C5 therapies is under review in China Approval was based on a P-III trial of ciprocopan vs Soliris in the above-mentioned pts, which met all 1 &…

ByRidhi Rastogi11 hours ago

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AstraZeneca Receives the EC Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

Shots: The EC has approved Etcamah + a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for adults with ER+, HER2- locally advanced or metastatic breast cancer with an ESR1 mutation & no progression on 1L endocrine therapy + CDK4/6 inhibitor; regulatory review is ongoing in the US Approval was based on the P-III (SERENA-6) trial assessing…

ByRidhi Rastogi14 hours ago

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GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

Shots: The US FDA has approved Jideytro (zidesamtinib) for the treatment of adults with locally advanced or metastatic ROS1-positive NSCLC who received a prior ROS1 kinase inhibitor Approval was based on the global P-I/II (ARROS-1) trial evaluating Jideytro in pts (n=117) with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor Trial showed meaningful & durable…

ByRidhi Rastogi2 days ago

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BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

Shots: The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26 Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…

ByRidhi Rastogi2 days ago

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NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Shots: NMPA has accepted the supplemental application of toripalimab + Pt-containing CT as perioperative treatment & subsequent monotx. as adj. therapy for the treatment of adult pts with resectable stage II-III NSCLC Filing was based on P-III (NEOTORCH) trial (n=501), which showed perioperative toripalimab + CT met 1EP of improved EFS by 60% (mEFS: not reached…

ByRidhi Rastogi3 days ago

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Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Shots: The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed…

ByRidhi Rastogi4 days ago

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Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

Shots: The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety…

ByRidhi Rastogi4 days ago

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GSK Reports EMA Submission Acceptance to Update Bexsero Label

Shots: The EMA has accepted a submission to update Bexsero’s label to incl. a single-dose booster for individuals (≥10yrs.) who were previously vaccinated with Bexsero Submission was backed by a P-IIIb study showing that a single Bexsero booster dose effectively enhanced immune responses in individuals (10–20yrs.) who completed primary vaccination series during infancy; full data…

ByRidhi Rastogi5 days ago

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Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

Lundbeck Secures the US FDA Fast Track designation for Lu AH69593 to Treat Narcolepsy

Nuvectis Pharma Reports NMPA Approval of Ciprocopan for Paroxysmal Nocturnal Hemoglobinuria (PNH)

AstraZeneca Receives the EC Approval for Etcamah (Camizestrant) to Treat Advanced Breast Cancer

GSK Reports the US FDA Approval of Jideytro for Previously Treated ROS1-Positive NSCLC

BridgeBio Pharma Reports the US FDA’s NDA Acceptance for Encaleret to Treat Autosomal Dominant Hypocalcemia Type 1 (ADH1)

NMPA Accepts Junshi Biosciences’ Toripalimab + CT Supplemental Filing for Resectable Stage II–III NSCLC

Kyowa Kirin Reports the EC Approval for Crysvita for X-Linked Hypophosphataemia

Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

GSK Reports EMA Submission Acceptance to Update Bexsero Label

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

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