Latest Biotech News

The FDA has approved Merck’s oral PCSK9 inhibitor enlicitide (Lipfendra) for adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia, marking the first approved oral...

GSK has ended development of camlipixant, its refractory chronic cough candidate, after mixed Phase 3 readouts failed to meet key goals across two studies (Calm-1 and Calm-2). While one dosing...

Johns Hopkins researchers reported Phase 1 results for a mutant KRAS peptide vaccine (mKRAS-VAX) aimed at intercepting pancreatic ductal adenocarcinoma in high-risk cohorts. In a study published...

Sarepta has launched a new Phase 3 trial for Elevidys (delandistrogene moxeparvovec) to address concerns raised by the European Medicines Agency. EMA denied marketing authorization after Elevidys...

Eli Lilly agreed to acquire AtaiBeckley in a deal valued at $2.8 billion upfront, with potential total consideration rising to about $3.8 billion tied to development and regulatory milestones. The...

Jasper Therapeutics is being renewed through a merger with Kira Pharmaceuticals, a move designed to stabilize the company after setbacks that reduced its market value and reshaped its clinical...

AdvanCell has raised a $315 million Series D financing to push a lead radiopharmaceutical candidate toward late-stage development while expanding isotope supply and manufacturing capacity. The...

Juno Bio raised $3.8 million and opened a CLIA-certified sequencing lab in Oakland, signaling an expansion of clinical testing capacity for its vaginal microbiome assay. The company said the assay...

A Science paper reports that AI-designed, synthetic RNA-guided nucleases can achieve activity that matches or outperforms natural reference enzymes, broadening the CRISPR toolbox beyond naturally...

Researchers reported data supporting a blood-based ctDNA profiling approach to better select patients for metastatic castration-resistant prostate cancer radiopharmaceutical therapy with...

Merck’s oral PCSK9 inhibitor enlicitide (LifpFendra) won U.S. FDA approval, giving the first once-daily pill option aimed at adults with hypercholesterolemia, including heterozygous familial...

The FDA approved Celcuity’s cancer therapy Revtorpyk, clearing the company’s first-in-class effort in a common breast-cancer setting. Reporting also highlighted that Wall Street didn’t expect...

Eli Lilly agreed to acquire AtaiBeckley in a deal valued at $2.8 billion upfront, with additional contingent value rights that could increase the total to $3.8 billion. The purchase gives Lilly a...

A first-in-human study reported that a mutant KRAS peptide vaccine (mKRAS-VAX) was safe and induced KRAS-specific T-cell responses in 90% of high-risk participants. After a median 16.5 months of...

Sarepta initiated an additional Phase 3 trial for Elevidys as it attempts to win European marketing authorization after EMA denied approval last year. The European Medicines Agency cited...

Leica Biosystems, part of Danaher, agreed to acquire Statlab Medical Products to expand its diagnostics and anatomical pathology portfolio with additional consumables and instruments. Financial...

AdvanCell secured an oversubscribed $315 million Series D financing to advance its radiopharmaceutical program and expand manufacturing capacity. The round is described as targeting late-stage...

Autolomous and Cellular Origins reported end-to-end integration of their cell-therapy manufacturing platforms, targeting greater automation and digitization across the production workflow. The...

CMS’ proposed 2027 Physician Fee Schedule would block Medicare reimbursement for remote patient monitoring delivered by third-party vendors. The policy is tied to Office of Inspector General...

GSK discontinued development of camlipixant, a P2X3 antagonist acquired in a $2 billion deal, after mixed Phase 3 results in refractory chronic cough. The first Phase 3 study met its primary...