Skip to content Skip to footer
Subscribe Now
NEWS

JenaValve’s Trilogy Transcatheter Heart Valve System Secures FDA Approval for Symptomatic, Severe Aortic Regurgitation (ssAR)

Shots: The US FDA has granted PMA approval to the Trilogy THV System to treat ssAR in pts at high or greater surgical risk, with immediate launch planned via participating study sites, followed by hospitals across the US Approval was supported by the results from ALIGN-AR pivotal IDE trial assessing safety & efficacy of the…
March 19, 2026

Read more

Merck Animal Health
NEWS

FDA Approves Merck Animal Health’s Bravecto Quantum to Treat and Protect Dogs from Asian Longhorned and Gulf Coast Tick

Shots: The US FDA has approved label expansion of Bravecto Quantum (Fluralaner for Extended-Release Injectable Suspension) for dogs to treat & control Asian longhorned tick (H. longicornis) & Gulf Coast tick (A. maculatum) for 12mos. The extended-release injectable Bravecto Quantum provides a once-yearly dosing option for improved compliance & continuous protection, & is available exclusively…
March 19, 2026

Read more

NEWS

Johnson & Johnson Reports the US FDA Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The US FDA has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy or phototherapy Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA…
March 19, 2026

Read more

Sanofi
NEWS

Sanofi’s Venglustat Secures the US FDA Breakthrough Therapy Designation for Type 3 Gaucher Disease

Shots: The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3) Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS  Venglustat received US…
March 18, 2026

Read more

NEWS

Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Shots: Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab) Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea) The…
March 18, 2026

Read more

NEWS

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

Shots: The US FDA has accepted the NDA of bezuclastinib for the treatment of NonAdvSM, with no advisory committee meeting planned or review issues identified yet (PDUFA: Dec 30, 2026) NDA was backed by SUMMIT trial, which met its 1 & 2EPs, showing sustained, deepening clinical benefit through 48wks., plus impact on bone mineral density…
March 18, 2026

Read more

NEWS

Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Shots: Ascendis Pharma has reported the P-II (New InsiGHTS) trial data assessing TransCon hGH (lonapegsomatropin, QW) vs somatropin (QD) in 49 prepubertal children (1-10yrs.) with Turner syndrome At Wk. 52, TransCon hGH showed improved annualized height velocity (AHV) with LS mean AHV of 9.05 vs 9.04 cm/year, irrespective of starting dose, with mean dose of…
March 18, 2026

Read more

NEWS

Voro Therapeutics Collaborates with Daiichi Sankyo to Develop Tumor-Activated ADCs

Shots: Voro Therapeutics has entered into a research collaboration with Daiichi Sankyo via its Daiichi Sankyo Research Institute, San Diego to develop tumor-activated biologics using the PrimeBody platform The collaboration will focus on generating masked ADCs designed for tumor-selective activation, using proprietary masking domains & protease-cleavable linkers to improve therapeutic index  Voro will design &…
March 18, 2026

Read more

Pfizer New
NEWS

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Shots: Pfizer has reported P-II (FOURLIGHT-1) trial data assessing atirmociclib + fulvestrant vs fulvestrant or everolimus plus exemestane in 264 pts with HR+, HER2- advanced or metastatic breast cancer who had received prior CDK 4/6 inhibitor-based treatment Trial met its 1EP, showing improved PFS as assessed by the investigator, with benefit consistent across all subgroups. OS…
March 17, 2026

Read more

Load more