Skip to content Skip to footer
Subscribe Now
BioCryst
NEWS

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…
May 16, 2025

Read more

Incyte
NEWS

The US FDA Approves Incyte’s Zynyz to Treat Adults with Squamous Cell Anal Carcinoma (SCAC)

Shots: FDA has approved Zynyz (retifanlimab-dlwr) + Pt-based CT as 1L treatment of inoperable locally recurrent or metastatic SCAC, & as monotx. for locally recurrent or metastatic SCAC progressing on or intolerant to Pt-based CT; EMA & PMDA’s application are under review Approval was based on P-III (POD1UM-303/InterAACT2) trial assessing Zynyz + Pt-based CT vs…
May 16, 2025

Read more

Abbvie
NEWS

AbbVie’s Emrelis Receives the US FDA’s Accelerated Approval for NSCLC With High c-Met Protein Overexpression

Shots: The US FDA has granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for treatment-experienced pts with locally advanced or metastatic, c-Met overexpressing, non-squamous NSCLC  Approval was backed by an ongoing P-II (LUMINOSITY) study assessing Emrelis as 2L/3L treatment of c-Met overexpressing NSCLC; showing an ORR of 35% & mDoR of 7.2mos. in pts (n=84) with…
May 16, 2025

Read more

Pet Pace
NEWS

TelmyVet and PetPace Launch Quality-of-Life Consultation to Support Pets and Families in End-of-Life Care

Shots: TelmyVet & PetPace have launched the Quality-of-Life Consultation, a virtual care service to support pets & their families during end-of-life stages Service combines TelmyVet’s telemedicine platform with PetPace’s AI-powered smart collar, which tracks HRV, vital signs, mobility, & behavior to assess pain & stress. It offers a supportive space for pet parent guidance &…
May 15, 2025

Read more

Genesys Spine
NEWS

Genesys Spine Unveils Stasys-C 3DP Cervical Standalone System to Streamline Anterior Cervical Procedures

Shots: Genesys Spine has launched its Stasys-C 3DP Cervical Standalone System to simplify anterior cervical procedures Stasys-C has a non-screw-based fixation method with quick, non-impacting anchor deployment via a direct anterior approach, plus it has Quick Turn Cam Lock, which allows visual anchor engagement & locking confirmation, while the SemaFour surface design maximizes wettability, surface…
May 15, 2025

Read more

Novo Nordisk and Septerna
NEWS

Novo Nordisk Enters a ~$2.2B Deal with Septerna to Develop Oral Small Molecules for Cardiometabolic Diseases

Shots: Septerna & Novo Nordisk to identify, develop & market oral small molecules for obesity, T2D & other cardiometabolic diseases under an exclusive global collaboration & license agreement As per the deal, Septerna will receive ~$2.2B, incl. over $200M in upfront & near-term milestones, plus research, development, & commercial milestones, along with net sales-based tiered…
May 15, 2025

Read more

Merck new
NEWS

Merck’s Welireg Receives the US FDA’s Approval for Pheochromocytoma and Paraganglioma

Shots: The US FDA has approved Welireg for the treatment of pts (≥12yrs.) with advanced, unresectable, or metastatic pheochromocytoma & paraganglioma (PPGL) Approval was based on Cohort A1 data from P-II (LITESPARK-015) trial assessing Welireg monotx. (120mg; QD) in 72 pts with unresectable or non-curable PPGL & stable blood pressure (BP <150/90 mm Hg, <135/85 mm…
May 15, 2025

Read more

Load more