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Axsome
NEWS

Axsome Therapeutics Reports the US FDA Approval of Auvelity to Treat Agitation Associated with Alzheimer’s Dementia

Shots: The US FDA has approved Auvelity (dextromethorphan HBr & bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease Approval was supported by an extensive clinical program incl. P-III (ADVANCE-1 & ACCORD-2), where ADVANCE-1 evaluated Auvelity vs PBO or bupropion over 5wks., while ACCORD-2 assessed Auvelity vs PBO in known responders In…
May 1, 2026

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Pfizer New
NEWS

Pfizer Reports the P-III (MagnetisMM-5) Trial Data on Elrexfio (Elranatamab) for R/R Multiple Myeloma (MM)

Shots: Pfizer has reported the P-III (MagnetisMM-5) trial data assessing Elrexfio monotx. (SC) vs daratumumab + pomalidomide & dexamethasone for the treatment of adults (n= 497) with r/r MM who received prior ≥1L of treatment Trial met its 1EP of improved PFS, as assessed by BICR, while OS data (2EP) remain immature & is under assessment; data…
May 1, 2026

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NEWS

Guardant Health and Nuvalent Partner on Precision Oncology Diagnostics

Shots: Guardant Health has entered into a multi-year strategic collaboration with Nuvalent to support the development & potential commercialization of Nuvalent’s oncology pipeline using the Guardant Infinity platform The partnership will use Guardant’s tissue & liquid biopsy tests to support Nuvalent’s global clinical studies & evaluate companion diagnostic development for Nuvalent’s investigational cancer therapies The…
May 1, 2026

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NEWS

LEO Pharma to Acquire Replay for Rare Skin Disease Gene Therapy Platform

Shots: LEO Pharma has entered into a definitive agreement to acquire Replay, expanding its dermatology pipeline with Replay’s herpes simplex virus-based gene therapy platform for rare genetic skin disorders As per the deal, LEO will acquire Replay for $50M upfront, plus milestone payments & tiered single-digit royalties, while adding Replay’s HSV design and manufacturing expertise…
May 1, 2026

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NEWS

BeOne Receives the US FDA Priority Review to  Tevimbra Combination for 1L Treatment of HER2+ GEA Cancers

Shots: FDA has granted priority review to BeOne's Tevimbra + Ziihera & CT for the 1L treatment of unresectable locally advanced/metastatic HER2+ gastric, GEJ, or esophageal adenocarcinoma; BeOne plans to participate in the FDA’s Project Orbis sBLA was based on the P-III (HERIZON-GEA-01) trial, which assessed Ziihera + CT ± Tevimbra vs Herceptin + CT as…
April 30, 2026

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NEWS

Laguna Biotherapeutics Reports the US FDA IND Clearance for LGNA-100 to Treat High-Risk Pediatric Leukemias

Shots: The US FDA has granted IND clearance to LGNA-100, Laguna Biotherapeutics’ lead clinical candidate from the QUAIL platform, to initiate the P-I trial The P-I single ascending dose study will assess safety, tolerability, & mechanism of LGNA-100 via IV infusion in pediatric & young adults with high-risk acute leukemias & MDS post αβ-depleted HSCT…
April 30, 2026

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NEWS

Huahui Health and BeOne Medicines Partner for HH160 in a ~$2.02B Deal

Shots: Huahui Health has entered into a global exclusive option, license & collaboration agreement, granting BeOne an exclusive option for the development, manufacturing, & commercialization of HH160, a novel trispecific antibody in oncology immunotherapy As per the deal, Huahui will receive $20M upfront, $100M upon exercising the option, & ~$1.9B in development, regulatory & sales milestones, as well as tiered…
April 30, 2026

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Henlius & Organon
NEWS

Henlius and Organon Receive the EC Approval for Poherdy (Biosimilar, Perjeta)

Shots: The EC has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product Approval was based on extensive data, incl. structural & functional analytical data, PK & clinical studies, which showed similarity & interchangeability in terms of analytical, PK, efficacy, safety, & immunogenicity between Poherdy &…
April 30, 2026

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