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Friday, April 10, 2026

Sanctioned tanker carrying Iranian crude anchored off India - report

 


A US-sanctioned very large crude carrier (VLCC) carrying Iranian oil is anchored near India’s Paradip port and could deliver a cargo of Iranian crude for the first time since 2019, according to shipping data cited by TankerTrackers.

The vessel, identified as Jaya, previously been linked to so-called “identity-switching” practices used by tankers involved in sanctions evasion, according to industry reports.

If discharged, the shipment would mark the first known delivery of Iranian crude to India in several years.

https://www.iranintl.com/en/liveblog/202604067622

'Iran retains thousands of missiles and hidden launchers despite strike - WSJ'

 


US intelligence assessments said Iran still retains thousands of ballistic missiles and is able to recover launchers stored in underground facilities despite recent US and Israeli strikes, according to The Wall Street Journal.

The report said Iran’s missile force has been significantly degraded but remains operational, with more than 1,000 medium-range ballistic missiles still in its arsenal from an estimated pre-conflict stockpile of around 2,500.

US officials said more than half of Iran’s launchers have been destroyed, damaged, or buried in underground sites, though many are believed to be repairable or retrievable from fortified mountain complexes.


https://www.iranintl.com/en/liveblog/202604067622

At least 9 of 14 ships in Strait of Hormuz linked to Iran after ceasefire - FT

 


Iran-linked vessels have accounted for the majority of recent transits through the Strait of Hormuz following a US-Iran ceasefire, the Financial Times reported on Friday.

At least nine of around 14 vessels that have passed through the strategic waterway since the pause in fighting were linked to Iran, including ships calling at Iranian ports, flying the Iranian flag or associated with Tehran’s maritime network, the FT said.

The report added that overall traffic through the Strait of Hormuz remains well below pre-conflict levels, with industry estimates suggesting commercial flows have yet to fully normalize.


https://www.iranintl.com/en/liveblog/202604067622

'Axios: US said to have asked Israel to pause Hezbollah strikes'

 The United States and Lebanon asked Israel to pause its direct strikes on Hezbollah, Axios reported on Friday.

According to two sources familiar with the matter, Lebanon asked Israel for this "gesture" ahead of the two countries' negotiations on April 14. The US, which will act as a mediator in the talks, passed on Lebanon's message to Israel. The sources added that the US supports Lebanon's demand and urged Israel to agree to it.

Previously, it was reported that Israeli Prime Minister Benjamin Netanyahu agreed to make the process of approving further strikes on Lebanon more sophisticated after a conversation with US President Donald Trump. Moreover, Iran insisted that any fruition of the negotiations with the US must include a ceasefire in Lebanon.

https://breakingthenews.net/Article/US-said-to-have-asked-Israel-to-pause-Hezbollah-strikes/66048934

Lebanon confirms US will mediate talks with Israel

 The Lebanese Presidency announced in a statement on Friday that Lebanese and Israeli ambassadors to the United States concluded their first call.

The presidency shared that the two sides officially agreed to meet on April 14 in Washington, confirming that the US Department of State will act as a mediator during the process.

The two sides will discuss "the announcement of a ceasefire and the date for starting negotiations between Lebanon and Israel under American sponsorship," it was written in the statement.

https://breakingthenews.net/Article/Lebanon-confirms-US-will-mediate-talks-with-Israel/66048599

Replimune’s advanced melanoma drug rebuffed by FDA for second time

 

The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.

Replimune’s stock fell nearly 20% Friday after the FDA rejected its advanced melanoma drug for the second time.

The FDA’s first rejection of RP1, an oncolytic immunotherapy also known as vusolimogene oderparepvec, in July 2025 sparked months of controversy, including an open letter from 22 researchers involved with the drug’s trials urging the agency to “re-review” its decision. Replimune resubmitted the application for the drug in October with new analyses on RP1’s mechanism of action and on how patients fared relative to prior treatment with an approved immunotherapy, a Replimune spokesperson told STAT News at the time.

The review team members for Friday’s decision were different from those who reviewed the company’s initial biologics license application, according to the FDA’s Complete Response Letter (CRL), which was published Friday. This was intended to “maintain objectivity and account for potential bias,” the agency said. Despite this, the team found the data presented was “insufficient to conclude substantial evidence of effectiveness” of RP1 in unresectable advanced cutaneous melanoma. RP1 was being proposed in combination with Bristol Myers Squibb’s Opdivo to treat the rare skin cancer.


Replimune’s use of a single-arm trial appears to be the sticking point for the FDA, which wrote in the rejection letter that it “would not recommend” seeking approval based on results from a single-arm study. The use of alternative trial designs, such as single-arm trials, has been a hot-button issue that drew many biotech onlookers to the FDA’s decision regarding RP1.

The FDA added in the letter to Replimune that its advice “has remained consistent as evidenced by our communications dating back to March 2021 and subsequent interactions.”

There appears to be a disconnect between the agency and Replimune, however, as CEO Sushil Patel expressed surprise with the initial rejection. “The issues highlighted in the CRL were not raised by the agency during the mid- and late-cycle reviews,” Patel said in a statement at the time. “Additionally, we had also aligned on the design of the confirmatory study.”

Analysts had given RP1 a 50/50 chance of approval this time around.

Replimune had been seeking accelerated approval for RP1. The company is currently conducting a randomized Phase 3 trial of the immunotherapy in combination with Opdivo, with an estimated completion date of January 2029.

https://www.biospace.com/fda/replimunes-advanced-melanoma-drug-rebuffed-by-fda-for-second-time

FDA probes abortion pill anew after court keeps mail access alive

 

A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.

The FDA is once again studying the safety of the abortion pill mifepristone just days after a federal Louisiana judge temporarily allowed the dispensing of the drug through mail.

“FDA continues to work on the collection of the robust and timely data that is necessary for a well-controlled study,” the agency wrote in an April 8 update to its website. The analysis will help the regulator decide whether it needs to make “substantive” changes to its Risk Evaluation and Mitigation Strategies for mifepristone, though it is unclear what such changes could look like.

“The agency is taking care to do this study properly and in the right way,” the FDA wrote, nevertheless adding that it wants to wrap up the study “as soon as possible.” Analyses such as these take “approximately a year or more” in academic settings, the regulator claimed, noting that “the current agency plan is to have this study done sooner than that.”

This new safety study comes a day after a Louisiana court blocked an attempt by Liz Murrill, Louisiana’s Attorney General, to prevent mifepristone from being dispensed to patients by mail. In a 37-page ruling on April 7, Judge David Joseph granted the FDA’s motion to press pause on the case while it conducts an assessment of mifepristone’s safety.

“The equities and the public interest weigh heavily in favor of FDA completing the job that the law requires it to do,” Joseph wrote. “At this juncture, it is the completion of FDA’s promised good faith, evidence-based, and expeditious review [of mifepristone’s safety] that this court finds to be in the public interest.”

Joseph, who was appointed by President Donald Trump, gave the FDA six months to provide the court “with the status of its review . . . and any updated timeframe for completion.”

Mifepristone is a progesterone blocker that is used to terminate pregnancies alongside another drug called misoprostol. It can also be used to treat high blood sugar in Cushing’s syndrome. Because of its role in inducing abortion, mifepristone has attracted controversy, particularly since federal protection of abortion rights was eliminated by the Dobbs v. Jackson Women’s Health Organization Supreme Court decision in 2022. In November 2022, for instance, the Alliance for Hippocratic Medicine filed a lawsuit against the FDA, asking to agency to pull its approval of the pill.

Then, in April 2023, Texas judge Matthew Kacsmaryk issued a preliminary injunction that blocked sales of mifepristone. This order kicked off a legal back-and-forth, at one point drawing an open letter from more than 480 biopharma leaders, and made it all the way to the Supreme Court. The letter called Kacsmaryk’s decision an “act of judicial interference” made “without regard for science or evidence.”

In June 2024, the High Court ruled to keep mifepristone available.

The fight over abortion access continued into 2025. In April, advocacy group Ethics and Public Policy Center published a report alleging that serious adverse events have developed in more than 10% of women on mifepristone. The report led health secretary Robert F. Kennedy, Jr. in May to tell the FDA to review its safety policies around the drug.

The anti-abortion report was “fundamentally, fatally flawed,” according to an open letter from 53 biotech executives and investors that asked the FDA to maintain access to mifepristone.

https://www.biospace.com/fda/fda-probes-abortion-pill-anew-after-court-keeps-mail-access-alive