Congress has repudiated the Trump administration’s slash-and-burn approach to biomedical research funding and rejected proposed structural reforms t...

Japan is entering its most dynamic biotech phase in decades. After years of undercapitalization, inward-facing company building, and a reliance on pharma g...

A dozen former FDA commissioners have sounded the alarm about radical changes to vaccine policy announced in an internal memo last week by CBER Director Vi...

Richard Pazdur’s decision to resign as CDER director and retire from FDA was precipitated by a memo CBER Director Vinay Prasad sent to his staff Fri...

CBER Director Vinay Prasad announced radial changes to FDA’s regulatory framework for vaccines in a memo sent to FDA staff on Friday, Nov. 28. As Bi...

China observers call it the world’s “toughest fitness center.” Get fit here, they say, and you can take on any challenge globally.I li...

On his first day as director of FDA’s Center for Drug Evaluation and Research, Richard Pazdur sent a letter to staff articulating his management phi...

In a stunning reversal, Richard Pazdur, who turned down the job last week, has agreed to serve as director of FDA’s Center for Drug Evaluation and R...

With a second “most favored nation” pricing deal, elements of the Trump administration’s drug pricing strategy came into focus last we...

The Senate passed the Biosecure Act Thursday evening as an amendment to the National Defense Authorization Act. Although the amendment was not included in ...

Molecular biologist David Baltimore, a Nobel laureate whose work bridged the worlds of science, medicine and public health, embodied the values that made U...

Despite headwinds facing the biotech industry, TCG Crossover’s Chen Yu believes the firm will deploy its new $1.3 billion fund during “a...

George Tidmarsh, director of FDA’s Center for Drug Evaluation and Research, argues FDA should be run like a biotech company, but a biotech CEO who p...

The Trump administration is laying the groundwork for an international reference pricing, or “most favored nation,” system for innovative med...

Former FDA Commissioner Scott Gottlieb warned Friday that restrictions on in-licensing medicines from China could trigger an international IP “arms ...

Last week, Cell published a study by researchers at the National Cancer Institute and Chinese universities who analyzed 90 datasets from 8,575 tumors to i...

The U.K. government will have to find common ground with pharmas on reimbursement if it wants to win the competition for life sciences investments. Fortuna...

Biopharma leaders view President Donald Trump’s push for “most favored nation” drug pricing as a serious, urgent threat. While there i...

FDA has issued a complete response letter for elamipretide, sending patients with Barth syndrome, along with the drug’s developer, Stealth Biotherap...

In the latest and largest deal between a China-based biotech and a larger biopharma for a bispecific with broad potential in oncology, Pfizer is paying 3SB...

FDA has missed another PDUFA review deadline, this time for a treatment that a small biotech is developing for an ultrarare disease. Stealth Biotherapeutic...

The takeout of Springworks by Merck KGaA will fortify the German company’s oncology business with a pair of approved drugs for rare tumors, while al...

Growing momentum at the Hong Kong stock exchange and chaotic policies from the White House may upend the longstanding IPO calculus for Asia’s biotec...

Bispecific antibodies and targeted protein degraders are front and center at this year’s AACR Annual Meeting, driving modality innovation, while pos...

What has become of Galapagos a little more than five years after its major partnership with Gilead is far from what the partners had envisioned for the meg...

YouTube video by Senator Chris Van Hollen

Shanghai ADC play Duality braved one of Hong Kong’s worst downturns of the past 20 years to stick its landing on the Stock Exchange of Hong Kong, of...

Biotech indexes are tumbling after one of FDA’s last veteran leaders was pushed out by HHS Secretary Robert F. Kennedy Jr. and the threat of tariffs...

Marty Makary is on track for Senate confirmation as FDA commissioner as soon as next week, but he’ll have little time for celebration. His immediate...

A little more than a year after the introduction of the Biosecure Act, the legislation appears to be dead and shares of the two companies most impacted by ...

With Congress facing a Friday deadline to pass legislation to avoid a government shutdown, lawmakers are considering a bill passed by the House that would ...

The temperature just went up a few more degrees for obesity’s hottest target now that Roche is spending nearly $1.7 billion up front to license...

WASHINGTON—Addressing the ongoing outbreak in Texas that has infected at least 124 state residents and killed one child, Health and Human Services Secretary Robert F. Kennedy Jr. vowed Thursday to mak...

Morale at FDA is sinking as news of firings, dubbed a Valentine’s Day massacre by agency staff, started ricocheting from Reddit threads and social m...