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Biotechnology Industry News

With the best-selling medication…

December 8th, 2025|FierceBiotech|

With the best-selling medication in the world in tirzepitide and a record-setting $1 trillion valuation to go with it, Eli Lilly is hardly hurting for cash. But money is only as good as what you

Amid an outpouring obesity data…

December 8th, 2025|FierceBiotech|

Amid an outpouring obesity data Monday, Wave Life Sciences and Structure Therapeutics were among the biotechs jockeying to set their weight loss assets apart in an increasingly crowded field as both companies saw their respective

A closer look at phase 3 data on…

December 8th, 2025|FierceBiotech|

A closer look at phase 3 data on BioNTech and OncoC4’s anti-CTLA-4 antibody has shown the efficacy that excited analysts last week is offset by a challenging tolerability profile.

Close to two years after AbbVie…

December 8th, 2025|FierceBiotech|

Close to two years after AbbVie handed over $48 million for the rights to Ose Immunotherapeutics’ inflammation drug, the Big Pharma now wants the French biotech to keep an eye on the asset for a

ORLANDO, Fla.—The leader of…

December 7th, 2025|FierceBiotech|

ORLANDO, Fla.—The leader of Gilead’s Kite Pharma is sure that anito-cel, the biotech’s next-generation multiple myeloma CAR-T challenger to Carvykti, is ready for prime time—and that the company is ready to bring CAR-T to the

ORLANDO, Fla.—With dosing…

December 6th, 2025|FierceBiotech|

ORLANDO, Fla.—With dosing underway in a pivotal phase 3 trial, Star Therapeutics is illuminating the clinical potential of its anti-bleeding antibody VGA039 with encouraging phase 1/2 results in a common bleeding disorder.

Novartis is divulging details from…

December 5th, 2025|FierceBiotech|

Novartis is divulging details from ianalumab’s phase 3 win in a rare autoimmune blood disorder, and the data suggest the treatment could delay the progression of patients to more serious forms of the disease

The industry’s mRNA alliance is…

December 5th, 2025|FierceBiotech|

The industry’s mRNA alliance is demanding steady FDA leadership, warning that the current “unprecedented turmoil” at the agency is eroding Americans' trust and threatening public health.

The FDA’s reported plan to move…

December 5th, 2025|FierceBiotech|

The FDA’s reported plan to move toward single-trial approvals has stirred industry concern, but one analyst views the proposal as a catalyst for greater R&D investment in the sector.

Encoded Therapeutics has linked…

December 5th, 2025|FierceBiotech|

Encoded Therapeutics has linked its Dravet syndrome gene therapy ETX101 to a 78% reduction in seizures, keeping the biotech on track to start a pivotal study next year.

Having already claimed a win for…

December 5th, 2025|FierceBiotech|

Having already claimed a win for the phase 2 study of its seizure drug, Praxis Precision Medicines is hoping fresh efficacy data will form the backbone of an approval application for its sodium channel inhibitor.

Pfizer’s VC arm has backed a…

December 5th, 2025|FierceBiotech|

Pfizer’s VC arm has backed a $100 million series A raise for OTR Therapeutics as the Chinese biotech tacks on preclinical neurological assets to its varied portfolio.

The top spot at the FDA’s Center…

December 4th, 2025|FierceBiotech|

The top spot at the FDA’s Center for Drug Evaluation and Research (CDER) has been a revolving door during President Donald Trump’s second term, and it took its latest shocking turn earlier this week: FDA

Pharma and biotech companies have…

December 4th, 2025|FierceBiotech|

Pharma and biotech companies have access to an unprecedented wealth of health data, from electronic health records and medical or pharmacy claims to genomic, behavioral and sensor data.

The FDA has placed a hold on…

December 4th, 2025|FierceBiotech|

The FDA has placed a hold on Denali Therapeutics’ plans to launch a phase 1 rare disease trial, citing concerns about immune reactions to the investigational treatment recorded in preclinical mouse studies.

Crescent Biopharma has agreed to…

December 4th, 2025|FierceBiotech|

Crescent Biopharma has agreed to pay Kelun-Biotech $80 million for ex-China rights to an antibody-drug conjugate, positioning the biotech to test the asset in combination with its PD-1xVEGF bispecific.