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BioWorld - Saturday, April 25, 2026
Home » Topics » U.S., BioWorld

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Idvynso

Merck wins US FDA nod for Idvynso, a two-drug HIV regimen

April 21, 2026
By Karen Carey
No Comments
Arriving a week ahead of April 28 PDUFA date, the U.S. FDA approval of Merck & Co. Inc.’s Idvynso (doravirine/islatravir) brings a new treatment option to adults with HIV-1 infection who are virologically suppressed. The approval is for those with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine.
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Former Jazz employee settles insider trading charge

April 21, 2026
By Mari Serebrov
No Comments
Another biopharma acquisition is at the heart of one of the U.S. SEC’s latest insider trading settlements. This time, the trading centered on Jazz Pharmaceuticals plc’s $935 million purchase of Chimerix Inc. last year.
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Global handshake silhouette

Biogen amasses full felzartamab rights with $850M TJ deal

April 21, 2026
By Marian (YoonJee) Chu
No Comments
Biogen Inc. has consolidated full global rights to felzartamab through an $850 million deal with TJ Biopharma Co. Ltd. April 20, closing the chapter on a complex 10-year license saga.
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Ajovy

Fed Circuit hands headache patent win back to Teva

April 21, 2026
By Mari Serebrov
No Comments
Ever since Teva Pharmaceutical Industries Ltd. sued Eli Lilly and Co. several years ago, claiming Lilly’s migraine drug, Emgality (galcanezumab), infringed its headache treatment patents, the two companies have been on a litigation rollercoaster.
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FDA Approved seal
Biopharma approvals March 2026

Targeted therapies dominate March’s five NME approvals

April 20, 2026
By Amanda Lanier
No Comments
U.S. FDA drug approvals totaled 19 in March 2026, matching February and showing a solid level of regulatory activity, though slightly below the 22 approvals recorded in March 2025 and under the spike of 30 seen in March 2024.
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Hand holding gear, dollar sign

Medtronic leads $100M financing round for Pulnovo

April 20, 2026
By Shani Alexander
No Comments
Pulnovo Medical Ltd. secured $100 million in a financing round led by Medtronic plc for its pulmonary artery denervation system to treat pulmonary hypertension.
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Sickle cell illustration

Novo’s Forma acquisition pays off with mitapivat competitor

April 20, 2026
By Brian Orelli
No Comments
Novo Nordisk A/S reported top-line results from the phase III Hibiscus study of its pyruvate kinase-R activator, etavopivat, which was acquired through the 2022 buyout of Forma Therapeutics Holdings Inc. The results set up a potential competition for patients afflicted by sickle cell disease with fellow PKR activator mitapivat from Agios Pharmaceuticals Inc.
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Gold-encircled handshake

Pleased to own ya, Kelonia: Lilly’s $7B CAR T deal

April 20, 2026
By Randy Osborne
No Comments
The already-thriving CAR T space took another big stride forward as Eli Lilly and Co. disclosed its plan to acquire Boston-based Kelonia Therapeutics Inc. for as much as $7 billion in cash, including an up-front payment of $3.25 billion, with the rest coming if clinical, regulatory and commercial goals are reached.
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Green arrow on blue abstract background

Psychedelic space expanding on Trump’s EO

April 20, 2026
By Mari Serebrov
No Comments
Timothy Leary is dead, but he could be on the outside looking in with a smile on his face as U.S. President Donald Trump’s latest executive order (EO) fuels a surge in investment in companies researching and developing psychedelic drugs to treat mental health issues. The EO, Accelerating medical treatments for serious mental illness, is intended to address the increasing burden of suicide and serious mental illness, which impacts more than 14 million Americans.
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Erica Schwartz, nominee for CDC director

New nominee may need a charm at the CDC

April 17, 2026
By Mari Serebrov
No Comments
As U.S. President Donald Trump’s third nominee for CDC director, Erica Schwartz will soon find out if three times really is a charm. Trump announced the nomination on social media April 16, touting Schwartz’s credentials for the job. Calling her “incredibly talented,” Trump cited her “distinguished career” as a military doctor, in the Navy and Coast Guard, and her service as deputy surgeon general during his first term in office.
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