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Cepheid wins FDA 510(k) for Xpert GI panel – rapid syndromic stool testing
Cepheid secured FDA 510(k) clearance for its Xpert GI Panel, a multiplex PCR assay that detects 11 gastrointestinal pathogens directly from stool in about 74 minutes on GeneXpert systems upgraded...
Guardant and Merck partner to co‑develop companion diagnostics for trials
Guardant Health and Merck announced a multi‑year collaboration to use Guardant’s liquid and tissue biopsy platforms to support enrollment and biomarker stratification in Merck’s global clinical...
Weill Cornell wins $5.2M ARPA‑H grant to fast‑track lymphatic diagnostics
Weill Cornell Medicine received an initial two‑year $5.2 million ARPA‑H LIGHT program grant to develop LANTERN (Lymphatic Disease Advancements with Nanotechnology, Translational Epigenetics, and...
GSK buys Rapt for $2.2B — long‑acting anti‑IgE joins pipeline
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a mid‑phase anti‑immunoglobulin E (IgE) antibody being developed to prevent food‑allergic reactions. The deal gives...
Boston Scientific to buy Penumbra for $14.5B — moves into thrombectomy
Boston Scientific agreed to acquire Penumbra in a $14.5 billion cash‑and‑stock transaction to shore up its cardiovascular and neurovascular portfolio. The deal buys Penumbra’s mechanical...
AstraZeneca pays up to $630M for China rights to GPC3 CAR‑T – global control secured
AstraZeneca agreed to acquire remaining China rights to Abelzeta Pharma’s C‑CAR031 (AZD5851), an autologous glypican‑3 (GPC3) CAR‑T for hepatocellular carcinoma, in a deal worth up to $630...
Valneva pulls chikungunya shot from U.S. — FDA safety probe prompts withdrawal
Valneva voluntarily withdrew its U.S. filings for the chikungunya vaccine Ixchiq and halted a suspended post‑marketing study after the FDA placed a clinical hold tied to a newly reported serious...
CMS backs Illumina CGP — reimbursement set at $2,989.55 per test
The U.S. Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay at $2,989.55 per test (PLA code 0543U), effective Jan. 1, 2026. The...
Cepheid cleared for multiplex Xpert GI panel — rapid syndromic GI testing arrives
Cepheid obtained FDA 510(k) clearance for its Xpert GI Panel, a multiplex PCR assay that detects and differentiates 11 gastrointestinal pathogens on GeneXpert systems, positioning the company in...
Guardant, Merck partner on companion diagnostics — liquid biopsies to support trials
Guardant Health signed a multi‑year agreement with Merck to develop and commercialize companion diagnostics using Guardant’s liquid and tissue biopsy platforms to support patient enrollment across...
Qiagen shares jump on sale speculation — advisers engaged, suitors eyed
Qiagen shares surged more than 15% after Bloomberg reported the diagnostics and life‑science tools company is working with advisers and has received interest from potential buyers. Market chatter...
FDA clears D3 Bio IND for KRAS G12D inhibitor — first‑in‑human trial to start
D3 Bio announced FDA clearance of an investigational new drug (IND) application for D3S‑003, a KRAS G12D small‑molecule inhibitor, enabling a first‑in‑human Phase I trial in patients with advanced...
Merck‑Moderna cancer vaccine sustains 49% melanoma risk cut at 5 years — durable adjuvant effect
Five‑year follow‑up data show that adding a Merck‑Moderna cancer vaccine candidate to Keytruda maintained a 49% reduction in risk of recurrence or death in melanoma patients, improving the...
GSK buys Rapt for $2.2B — bets on long‑acting anti‑IgE
GSK agreed to acquire Rapt Therapeutics for $2.2 billion to add ozureprubart, a long‑acting anti‑IgE monoclonal antibody for food allergy, to its pipeline. Ozureprubart is in a Phase IIb prestIgE...
AstraZeneca pays up to $630M for China CAR‑T rights
AstraZeneca agreed to pay up to $630 million to acquire China rights to Abelzeta Pharma’s C‑CAR031 (AZD5851), an autologous CAR‑T targeting glypican‑3 for hepatocellular carcinoma. The deal gives...
Qiagen mulls sale: shares jump on buyout chatter
Qiagen shares surged after Bloomberg reported the company is working with advisers and has held talks with potential suitors about a possible sale. The report cited unnamed people with knowledge...
Valneva withdraws U.S. chikungunya filing amid safety probe
Valneva announced it has voluntarily withdrawn its U.S. submissions for Ixchiq, its chikungunya vaccine, after the FDA placed a clinical hold on a post‑marketing study following a newly reported...
CMS backs Illumina test — reimbursement opens precision oncology door
The Centers for Medicare & Medicaid Services granted reimbursement for Illumina’s TruSight Oncology Comprehensive assay under PLA code 0543U at $2,989.55 per test, effective Jan. 1, 2026. The...
Capricor updates BLA amid FDA review of HOPE‑3 topline data
Capricor Therapeutics issued a regulatory update on its Biologics License Application for Deramiocel after the FDA reviewed topline data from the HOPE‑3 study. Deramiocel is an investigational...
Merck, Moderna cancer vaccine sustains 49% melanoma risk cut at 5 years
Five‑year follow‑up data show adding Merck and Moderna’s investigational cancer vaccine to Keytruda sustained a 49% reduction in risk of recurrence or death in melanoma, reinforcing the...