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Roche gets FDA decision date on oral SERD giredestrant
Roche announced the FDA will decide by Dec. 18 whether to approve giredestrant, its oral selective estrogen receptor degrader (SERD) for ER‑positive, HER2‑negative breast cancer. The submission...
Ionis halts Alzheimer’s candidate for people with Down syndrome
Ionis Pharmaceuticals discontinued development of an investigational Alzheimer’s therapy targeted to people with Down syndrome, according to company statements reported by Endpoints News. The move...
Bioversys shows early clinical proof‑of‑concept in tuberculosis
Antibiotics specialist Bioversys reported Phase IIa early bactericidal activity for alpibectir (BVL‑GSK098) in combination with ethionamide for pulmonary tuberculosis, with findings published in...
New structural insights open target space in bacterial DNA control
Researchers revealed structural and mechanistic details of bacterial regulation of ribonucleotide reductase (RNR) expression via the NrdR regulator, illuminating a control node unique to...
Insilico and Lilly map a ‘prompt‑to‑drug’ autonomous R&D future
Insilico Medicine and Eli Lilly published a framework in ACS Central Science outlining a vision for fully autonomous 'prompt‑to‑drug' pharmaceutical R&D that stitches generative AI models into...
Japan backs first iPSC‑derived therapies under conditional approvals
Japan’s regulatory advisory body recommended conditional early approvals for Amchepry (raguneprocel) and Reheart, positioning them to become the world’s first iPSC‑derived therapies to receive...
FDA reverses: Moderna’s mRNA flu shot moved back into review
The FDA agreed to reconsider Moderna’s seasonal mRNA influenza vaccine mRNA-1010 after a rapid Type A meeting, setting a target PDUFA date of August 5. Moderna proposed an age‑stratified...
Grail’s Galleri misses primary goal — market rout follows
Grail’s large NHS‑Galleri multicancer early detection (MCED) trial did not meet its primary endpoint of a statistically significant reduction in combined stage III–IV cancers, top‑line results...
Guardant expands screening push — buys MetaSight and lifts Shield outlook
Guardant Health acquired MCED startup MetaSight Diagnostics for $59 million upfront plus contingent payments and projected strong growth for its Shield colorectal screening product in 2026....
FDA clears Vanda’s Bysanti — new antipsychotic approval
The FDA approved Vanda Pharmaceuticals’ Bysanti for schizophrenia and for acute manic or mixed episodes in bipolar I disorder. Bysanti is an active metabolite of an existing atypical antipsychotic...
Japan backs two iPSC therapies under conditional pathway
Japan’s regulatory advisory panel recommended conditional, time‑limited endorsements for two induced pluripotent stem cell (iPSC)‑derived therapies: Amchepry (raguneprocel) from Sumitomo...
RNR regulation decoded — structural insights point to new antibacterial targets
New structural and mechanistic work on ribonucleotide reductases (RNRs) and their bacterial regulator NrdR has clarified how bacteria control dNTP synthesis, exposing bacterial‑specific control...
Disorder helps: messy lipid nanoparticles improve RNA delivery
Single‑particle analyses revealed two LNP subpopulations — organized and amorphous — and showed that the disordered, 'messy' nanoparticles release RNA cargo more effectively inside cells....
AI arms race in drug discovery — autonomous 'prompt‑to‑drug' vs closed proprietary models
Insilico Medicine and Eli Lilly published a vision paper outlining an end‑to‑end autonomous 'prompt‑to‑drug' R&D framework that chains generative AI tools into integrated discovery workflows. The...
CAR‑NK tweaks boost tumor killing in preclinical models
Researchers at the Ribeirão Preto Blood Center and the University of São Paulo’s Center for Cell‑Based Therapy reported novel approaches that enhance CAR‑NK efficacy using the NK‑92 cell line. The...
Diagnostics consolidation and new platforms reshape testing market
Danaher agreed to acquire patient monitoring firm Masimo in a roughly $9.9 billion cash deal while Cepheid was selected as one of four CDC collaborators under a rapid‑diagnostics IDIQ aimed at...
Grail’s Galleri misses endpoint — shares plunge
Grail reported that its large NHS-Galleri multicancer early detection (MCED) trial did not meet the primary endpoint of a statistically significant reduction in late-stage (III–IV) cancer...
FDA reverses course: Moderna flu vaccine under review
The FDA reversed a recent refusal-to-file decision and agreed to accept Moderna’s application for review of its mRNA influenza vaccine, mRNA‑1010, after a Type A meeting between the agency and the...
Guardant expands screening play — MetaSight buy and Shield ramp
Guardant Health disclosed an acquisition of early‑cancer detection startup MetaSight Diagnostics and issued guidance expecting material growth in its Shield colorectal‑cancer screening business...
Danaher shells out nearly $10B for Masimo — diagnostics consolidation
Danaher entered a definitive agreement to acquire Masimo Corporation for approximately $9.9 billion ($180 per share), accelerating Danaher’s push into acute‑care monitoring and diagnostics. The...