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FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals
Food and Drug Administration Commissioner Marty Makary warned that the U.S. is falling behind China in early-stage drug development and called for reforms that could streamline the process for starting trials on new treatments.
In an interview with CNBC on Wednesday, Makary specifically pointed to three bottlenecks that he said cause the U.S. to fall behind on those early drug trials.
These include hospital contracting as well as ethical reviews and approvals, both of which he called “clunky processes that take too long and are leaving us noncompetitive with the countries that are moving a lot faster.” He also pointed to the process for submitting and receiving approvals for Investigational New Drug, or IND, applications, which companies submit to test a product in humans.
“We walked into a mess,” Makary said, referring to how behind China the U.S. was in terms of Phase 1 clinical trials conducted in 2024.
Food and Drug Administration Commissioner Marty Makary speaks in the Oval Office at the White House on Jan. 29, 2026.
Samuel Corum | Getty Images
He said the FDA is “looking at everything,” such as whether it can partner with health systems and academic medical centers on the pre-IND process. That refers to when companies consult the FDA before formally filing an application.
Makary said the Trump administration should “partner with industry to help them deliver more cures and meaningful treatments for the American public because that is a common bipartisan goal that we all want. And we’re going to get it done in this administration.”
China’s biotech ecosystem has flourished over the last several years, driven by massive state investment, a vast talent pool and accelerated regulatory reforms. Once known for being a low-cost manufacturing base that pumps out copycats, China is rapidly evolving into a global innovation powerhouse.
Data from Global Data and Morgan Stanley shows that China now conducts more clinical trials than the U.S., accounts for nearly a third of new global drug approvals and is on pace to reach 35% of FDA approvals by 2040.
U.S. policymakers have been under pressure to take steps to boost innovation domestically.
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Sir Keir Starmer says it is “deeply concerning” the rapper is set to headline a festival after recent antisemitic comments.
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Stock markets outlook: Dalal Street braces for swings as RBI MPC decision, war risks weigh on sentiment–Check key triggers – The Times of India
Domestic equities are expected to remain volatile this week as investors track the Reserve Bank’s monetary policy decision, global macroeconomic cues and evolving developments in the West Asia conflict, analysts said, according to PTI.Market participants will also keep a close watch on crude oil price movements and foreign fund flows, which continue to influence sentiment.Vinod Nair, Head of Research at Geojit Investments Ltd, said the RBI’s Monetary Policy Committee (MPC) meeting will be the key domestic trigger, with investors focusing on the central bank’s stance on inflation and growth.“A rate pause is near-certain consensus, the central bank walks a tightrope between crude-driven inflation risks and a four-year low Manufacturing PMI signalling a softening growth impulse. The governor’s commentary on the rate cycle trajectory and FY27 projections will be closely monitored.“Globally, the US March CPI reading will carry significant importance, as it buries residual Fed rate-cut hopes, strengthens the dollar and tightens financial conditions for emerging markets, including India,” Nair said.He added that geopolitical developments in West Asia will remain the dominant factor shaping market direction.“Indian markets return after a three-day gap and remain acutely vulnerable to weekend war developments, with crude trajectory and any credible ceasefire signal being the decisive variable that could either trigger a sharp relief rally or extend the current sell-on-rise mode,” he said.In the previous holiday-shortened week, the BSE Sensex declined 263.67 points, or 0.35%, while the NSE Nifty fell 106.5 points, or 0.46%.Siddhartha Khemka, Head of Research (Wealth Management) at Motilal Oswal Financial Services Ltd, said investor sentiment will remain closely linked to developments in the West Asia conflict.Brent crude prices have stayed elevated near $107 per barrel, fuelling concerns around imported inflation. Currency pressures have also intensified, with the rupee weakening sharply before recovering towards Rs 93 against the US dollar following RBI intervention, he noted.Foreign institutional investor (FII) outflows remain a key overhang, with March witnessing heavy selling of Rs 1.2 lakh crore, among the highest monthly outflows in recent years.“Investors will monitor the US Federal Open Market Committee (FOMC) meeting minutes, GDP data, and initial jobless claims for further cues on growth and the policy trajectory.“Overall, markets are expected to remain volatile as geopolitical developments, crude price movements, FII flows and global macro data continue to drive sentiment,” Khemka said.Analysts said any signs of de-escalation in the West Asia conflict could ease crude prices and stabilise the currency, offering relief to markets, while further escalation may prolong risk aversion and keep pressure on foreign flows.
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Home heating oil costs in rural Lancashire doubles – councillors
One elderly couple had to find £1,000 for an oil delivery and suppliers are not giving quotes, a councillor says.
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