Tidmarsh will temporarily guide CBER’s regulatory activities while the FDA searches for a permanent department lead.

Biotechs investigate mitochondria-targeting drugs to claim a share in the weight loss drug market dominated by GLP-1RAs.

Sanofi expanded the sales reach of the drug with approvals in the lucrative chronic obstructive pulmonary disease (COPD) market. Dupixent’s success pushed Sanofi’s total net sales to €9.9bn, up 10% at ...

Director-general for WHO says leaders want self-reliance, with tobacco and alcohol tax rises on the cards to boost domestic revenue.

Viridian and Kissei Pharmaceutical have signed an exclusive partnership and license agreement for advancing veligrotug and VRDN-003.

The Maryland Prescription Drug Affordability Board (PDAB) found that Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin) present affordability ...

We spoke to BBG Advanced Therapies COO Adrienne Mendoza to learn how one company is tackling the challenges of cell therapies.

ViroCell Biologics has partnered AvenCell Therapeutics for development of new allogeneic CAR-T therapies to treat blood cancers.

CEO-to-be Maziar Mike Doustdar will need to stem the company’s tumbling share price as market pressures intensify.

Analysts say the departure of the CBER head may alleviate overhang in the cell and gene therapy space. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and ...

GSK's Q2 results show that sales of its specialist oncology assets have risen by 42%, while general drug sales were down 6%.

Despite being significantly lower than the 200% rate threatened by Trump, the deal is set to ramp up drug costs by billions.