Industry News

On May 14, 2025, the Food and Drug Administration granted accelerated approval to telisotuzumab vedotin-tllv (Emrelis, AbbVie Inc.), a c-Met-directed antibody and microtubule inhibitor conjugate, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression [≥50% of tumor cells with strong (3+) staining], as determined by an FDA-approved test, who have received a prior systemic therapy.

BAAR, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) announced today that Optune Lua® has received a CE (Conformité Européenne) Mark for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) concurrently with immune checkpoint inhibitors or docetaxel who have progressed on or after a platinum-based regimen.

DUBLIN and DURHAM, N.C., March 05, 2025 (GLOBE NEWSWIRE) -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) (“Jazz” or the “Company”) and Chimerix (Nasdaq: CMRX) (“Chimerix”), today announced the companies have entered into a definitive agreement for Jazz to acquire Chimerix for $8.55 per share in cash, representing a total consideration of approximately $935 million. The transaction has been approved by both companies and is expected to close in the second quarter of 2025.

BURLINGTON, Mass.--(BUSINESS WIRE)--PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the latest National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025, January 21, 2025) now highlight the substitution of ropeginterferon alfa-2b-njft (BESREMi®) for treating polycythemia vera (PV) in the event that peginterferon alfa-2a (Pegasys®) is unavailable.

STAMFORD, Conn., Feb. 11, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has approved GOMEKLI™ (mirdametinib), SpringWorks’ MEK inhibitor, for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.1

BOSTON, January 17, 2025 - Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

The first interim analysis of the Phase 2 COCOON study met its primary endpoint, demonstrating that an easy-to-use and readily available regimen significantly reduced the frequency of moderate-to-severe skin and nail side effects (Grade 2 or higher) and severity of skin-related side effects compared to standard dermatological management in patients receiving first-line treatment with RYBREVANT® (amivantamab-vmjw) and LAZCLUZE™ (lazertinib).

RARITAN, N.J., January 15, 2025 – Johnson & Johnson (NYSE: JNJ) announced it has initiated the submission of an original New Drug Application with the U.S. Food and Drug Administration (FDA) for TAR-200 for the treatment of patients with Bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

RARITAN, N.J., January 7, 2025 – Johnson & Johnson (NYSE:JNJ) today announced positive topline results for the gold standard endpoint in cancer treatment of overall survival (OS) from the Phase 3 MARIPOSA study, evaluating RYBREVANT® (amivantamab-vmjw) plus LAZCLUZE™ (lazertinib) as a first-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution mutations.

NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuximab (marketed as ERBITUX® ) and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test.i