Latest Biotech News

Artificial intelligence is increasingly reshaping biotech research and healthcare. New AI models have enabled advances in traditionally undruggable targets such as intrinsically disordered...

Several pharmaceutical programs face setbacks impacting clinical and regulatory outlooks. Bristol Myers Squibb’s anemia drug Reblozyl failed its Phase 3 trial in myelofibrosis-associated anemia,...

Heartflow Inc. recently submitted its S-1 filing to the SEC, adding to a growing list of medtech companies pursuing public offerings in 2025, signaling robust investor interest in the sector....

MolDx program’s proposed local coverage determination (LCD) would restrict the frequency of molecular surveillance testing for transplant rejection, setting limits substantially below current...

An FDA convened panel of medical experts urged the removal of black box warnings on menopausal hormone therapy (MHT), citing benefits outweighing risks in symptomatic relief and potential...

Sarepta Therapeutics is under increased scrutiny following the deaths of three patients linked to its gene therapies for muscular dystrophy. Two teenagers died after treatment with Elevidys, the...

Recent FDA advisory committee votes have rejected Otsuka's PTSD drug Rexulti-Zoloft combination after concerns about failed Phase 3 trials and safety issues. Concurrently, a panel urged the...

Scipher Medicine is broadening its focus beyond diagnostics to drive precision medicine development. The company leverages the largest non-oncology clinical transcriptomic dataset, secured through...

The intersection of AI with biotech research advances therapeutic targeting and drug discovery. Nobel laureate David Baker's lab developed AI models to design binders for intrinsically disordered...

Venture funding for biotech startups declined sharply in Q2 2025, reflecting broader market contractions and fundraising difficulties. Despite this, late-stage financings and IPO activity...

June 2025 saw significant FDA activity including approvals for Gilead’s twice-yearly HIV preventive shot and Nuvation Bio’s ROS1 inhibitor for lung cancer, reflecting continued innovation in...

GenesisM has commenced construction of a major 154,000 square-foot biomanufacturing facility in Bedford, Massachusetts, expanding capacity in the Boston area’s leading biopharma cluster. The...

GSK faced an FDA advisory committee rejection over safety and dosage concerns for its multiple myeloma drug Blenrep, complicating its return to the U.S. market. Simultaneously, CareDx’s stock...

Artificial intelligence is increasingly shaping biopharma innovation and clinical practice. From AI models diagnosing structural heart disease via ECG, to spatial transcriptomics projects...

Sarepta Therapeutics faces major scrutiny following the deaths of three patients linked to its gene therapies for muscular dystrophies. Two teenage patients treated with Elevidys for Duchenne...

Sarepta’s CEO Douglas Ingram addressed recent concerns around transparency, defending the company’s disclosure practices amid criticism over delayed public acknowledgement of patient deaths in...

The FDA’s advisory committees delivered notable decisions impacting drug approvals. The Psychopharmacologic Drugs Advisory Committee voted 10-1 against approving Otsuka’s Rexulti combined with...

Scipher Medicine, known for its molecular diagnostics in rheumatoid arthritis, is pivoting toward broad precision medicine applications beyond oncology. Under CEO Reg Seeto, the company is...

The FDA approved 22 new drugs in June 2025, tying for the highest monthly total this year and contributing to 107 approvals in the first half of 2025. Notable approvals include Gilead’s...

Biopharma financing activity showed nuanced trends with seed and Series A funding rising in first half 2025, though the total number of contributing companies decreased. In med-tech, companies...