Departing FDA leader Robert Califf defended the agency’s record and praised its progress on regulating food

In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about controversial decision during his term.

Johnson & Johnson says its bispecific antibody, paired with a Janssen drug, could change treatment for non-small lung cancer patients.

The FDA published its first draft guidance on the use of AI in the development of drugs and biological products

Novo Nordisk filed another petition with the FDA seeking to block compounding pharmacies from making versions of one of its GLP-1 drugs

The alcohol industry relies on the myth of “responsible enjoyment” to downplay its products’ risks while spreading misinformation to stifle regulation.

Indian-Americans who remember life before the polio vaccine are worried about what RFK Jr. could do in the U.S.

After multiple short-term extensions, telehealth providers are eager for Congress to lay out its long-term plans for the sector.

U.S. senators and other lawmakers argue the problems created by UnitedHealth's size and reach demand steps to restore public confidence in the health care system

Novo Nordisk’s next-generation obesity candidate led to substantial weight loss in a pivotal study but fell short of expectations

Vertex's closely watched drug, suzetrigine, reduced sciatica pain compared to baseline but did not outperform a placebo

Merck signed a deal worth up to $2 billion with Hansoh Pharma to develop and sell the Chinese biotech's oral obesity drug

Former FTC policy director David Balto says PBMs should be very worried about the new Trump administration and pending congressional action.

After two years of haggling, Congress has nearly reached a deal to rein in pharmacy benefit managers

Novo Holdings can proceed with its planned $16.5 billion acquisition of Catalent after U.S. regulators declined to challenge the deal

Ionis is expecting a FDA decision by Dec. 19 on approval of a drug designed to improve the body’s ability to break down fats

Most patients with chronic lymphocytic leukemia eventually relapse. A bispecific antibody drug may give them "another can to kick."

Editas plans to lay off 65% of its staff — around 180 employees — as it shelves its lead gene-editing program for sickle cell disease

Gilead plans to begin Phase 3 testing soon for a drug it believes could prevent HIV infection with a single shot every year

Akshara Ramasamy will soon begin medical school in Texas — but the state’s new requirement to ask hospital patients about immigration status worries her.

A bipartisan group of senators are filing a bill that would force health insurers or PBMs to divest their pharmacy businesses

New data suggests researchers may have found one of their most promising candidates yet for the next generation in immunotherapy drugs — bispecific antibodies targeting two key proteins in cancer, PD1 or PD-L1 and VEGF.A small early trial on one such

Why digital measurements startup Koneksa Health thinks it can help pharma measure if their drugs are effective in people with Parkinson's disease.

The pharmaceutical industry is not lobbying senators to stop the confirmation of long-time critic Robert F. Kennedy Jr.

The BIOSECURE Act, which would restrict drugmakers from using key Chinese contract manufacturers, was left out of a defense budget bill 

Ambros and Lee's collaboration helped spawn a new field of biology while proving breakthrough science can come out of a family-friendly lab

The diverse alliance that makes up the MAHA movement is showing some cracks over Trump's picks to lead health-related agencies

WASHINGTON — The Food and Drug Administration has always believed it has the power to regulate tests made in labs. But it was only under President Biden that it began actively exercising that authority, releasing a policy in April telling labs they h

Algorithms that help to analyze CT scans, MRIs, and X-rays account for more than three-quarters of AI-based devices authorized by the FDA.

FDA Commissioner Robert Califf told lawmakers they must invest more in the agency for it to rein in the food industry further.