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NEWS

Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility

Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…
April 21, 2026

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Moderna
NEWS

Moderna Reports the EC Approval of mCOMBRIAX to Protect Against Influenza and COVID-19    

Shots:  The EC has approved mCOMBRIAX (mRNA-1083), a combination vaccine for the prevention of influenza and COVID-19 in patients ≥50 yrs. across all 30 EEA states    Approval was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone / Efluelda (a high dose influenza vaccine )+ Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability    MRNA-1010, Moderna’s…
April 20, 2026

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Bavarian Nordic
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Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…
April 17, 2026

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NEWS

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk…
April 16, 2026

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Merck new
NEWS

Merck Report the EC Approval of Enflonsia for RSV Prevention in Infants 

Shots:  The EC has approved Enflonsia (clesrovimab) to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk infants  The Phase 2b/3 CLEVER trial (N=3,614) evaluated in infants entering their first RSV season. Enflonsia reduced RSV-associated medically attended LRIs…
April 15, 2026

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NEWS

Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion sBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in…
April 15, 2026

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Travere Therapeutics
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Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Shots: The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome Approval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration…
April 14, 2026

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