WebMD

Rybrevant Faspro: FDA Approves Once-Monthly Dosing in Combination With Lazcluze for EGFR-Mutated Lung Cancer

What Is It, and Why Does It Matter? Rybrevant Faspro is an under-the-skin (subcutaneous, or SC) injection form of the anticancer medicine Rybrevant (amivantamab). The FDA has approved a new monthly ...
Seeking Alpha

FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

Builds on RYBREVANT FASPRO™ FDA approval to deliver the simplest and fastest combination regimen for EGFR+ non-small cell lung cancer 1,3-6 HORSHAM, Pa., Feb. 17, 2026 /PRNewswire/ -- Johnson & ...
Nasdaq

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) plus immunotherapy shows strong clinical benefit with 56 percent overall response rate in first-line recurrent or ...

RARITAN, N.J., Feb. 19, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced new results from the Phase 1b/2 OrigAMI-4 study showing that first-line treatment with investigational ...
Morningstar

RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) pivotal data show strong and durable responses in advanced head and neck cancer where options remain limited

CHICAGO, May 31, 2026 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj ...
Business Insider

Janssen Submits Applications in U.S. and EU Seeking Approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj)/DARZALEX® (daratumumab) Subcutaneous (SC) Formulation ...

In this pooled safety population, injection-site reactions occurred in 8% of patients, including Grade 2 reactions in 0.6%. The most frequent (>1%) injection-site reaction was injection site erythema.
Nasdaq

DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high-risk smoldering multiple myeloma

HORSHAM, Pa., Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a ...
Seeking Alpha

U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with ENHANZE® for the Treatment of Advanced EGFR-mutated Non-Small Cell Lung Cancer

SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for ...
WebMD

FDA Approves Darzalex Faspro as Part of a New First-Line Quadruplet Regimen for Multiple Myeloma

What Is Darzalex, and Why Does It Matter? Darzalex Faspro is an injectable medicine used to treat adults with multiple myeloma, a type of blood cancer, and light chain (AL) amyloidosis, a rare ...
Daily Local News

Janssen Announces U.S. FDA Approval of DARZALEX FASPRO(R) (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple ...

HORSHAM, Pa., July 12, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (R) ...
Monthly Prescribing Reference

Darzalex Faspro Approved for High-Risk Smoldering Multiple Myeloma

Darzalex Faspro reduced the risk of disease progression to active multiple myeloma or death by 51% compared with active monitoring. The Food and Drug Administration (FDA) has approved Darzalex Faspro ...
Yahoo Finance

FDA approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month

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