U.S.

Targeted therapies dominate March’s five NME approvals

Mon, 20 Apr 2026 12:00:00 -0400

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.

Medtronic leads $100M financing round for Pulnovo

Mon, 20 Apr 2026 12:00:00 -0400

Pulnovo Medical Ltd. secured $100 million in a financing round led by Medtronic plc for its pulmonary artery denervation system to treat pulmonary hypertension.

Novo’s Forma acquisition pays off with mitapivat competitor

Mon, 20 Apr 2026 12:00:00 -0400

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.

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

Mon, 20 Apr 2026 12:00:00 -0400

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.

Psychedelic space expanding on Trump’s EO

Mon, 20 Apr 2026 12:00:00 -0400

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.

New nominee may need a charm at the CDC

Fri, 17 Apr 2026 12:00:00 -0400

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.

Obesity-focused Kailera goes for US biopharma record with $625M IPO

Fri, 17 Apr 2026 12:00:00 -0400

Kailera Therapeutics Inc.’s “obesity-first” approach continues to resonate with investors, with the company pricing an upsized IPO, offering 39 million shares at $16 apiece for gross proceeds of $625 million. Full exercise of the underwriters’ option could add another $93.8 million, bringing the total to nearly $719 million, easily topping Sana Biotechnology Inc.’s $675.6 million 2021 IPO and setting a new record for U.S. biopharma IPOs, according to BioWorld data.

HHS budget hearing not so much about budget

Thu, 16 Apr 2026 12:00:00 -0400

U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.

Foundation Medicine buying Saga Dx and its MRD test for $595M

Thu, 16 Apr 2026 12:00:00 -0400

Nearly a year after the first U.S. commercial launch of the multicancer molecular residual disease (MRD) detection platform Pathlight, developer Saga Diagnostics entered a definitive merger agreement under which Roche Holding AG subsidiary Foundation Medicine Inc. will take over the firm in return for up to $595 million in payments.

Abbott cuts 2026 profit forecast on Exact deal, shares fall

Thu, 16 Apr 2026 12:00:00 -0400

Abbott Laboratories saw its shares fall in early trading April 16 after cutting its guidance for 2026 on the back of dilution related to its $21 billion acquisition of Exact Sciences Corp. The company revised its full year adjusted earnings per share guidance to $5.38 to 5.58, down from $5.55 to $5.80 previously. The updated outlook includes 20 cents of dilution related to the Exact deal. Abbott also reported first quarter profits of $1.08 billion, down 18.7% from a year ago.

Maryland 340B law likely pre-empted, appeals court rules

Thu, 16 Apr 2026 12:00:00 -0400

Given its recent decision in a challenge to a West Virginia law, it’s no surprise that the U.S. Court of Appeals for the Fourth Circuit issued a 2-1 unpublished opinion April 14 overturning a lower court that had refused a preliminary injunction to stall a similar Maryland law that would require drug manufacturers to offer 340B prescription drug discounts to unlimited contract pharmacies.

Flow of Trump EOs slowing way down

Wed, 15 Apr 2026 12:00:00 -0400

Despite key vacancies, ongoing staffing challenges and policy issues at the U.S. CDC, FDA and NIH, some of the regulatory churn that roiled those agencies in the first year of the second Trump administration is settling a bit, at least in terms of the number of executive orders (EOs) coming out of the Oval Office.

Revolution Medicines’ $1.5B follow-on highest to date

Wed, 15 Apr 2026 12:00:00 -0400

In what shakes out to be the largest follow-on stock offering in biopharma history, Revolution Medicines Inc., an oncology company that was the subject of buyout rumors earlier this year, priced 10.56 million shares to raise $1.5 billion just two days after wowing investors with top-line phase III data of its RAS inhibitor daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma.

New guidance advises on assessing safety of gene editing

Wed, 15 Apr 2026 09:00:00 -0400

The U.S. FDA’s latest draft guidance on gene therapies focuses on nonclinical studies using next-generation sequencing-based methods and bioinformatics to evaluate safety risks associated with off-target editing and loss of genome integrity in human gene-edited products.

More of everything as Amazon moves into AI-driven drug R&D

Wed, 15 Apr 2026 09:00:00 -0400

Amazon is extending the reach of its “everything store” into drug R&D with the launch of an artificial intelligence-powered Bio Discovery business. The company has compiled a catalogue of 40-plus foundation models that have been trained on extensive biology datasets and are able to generate and evaluate drug molecules in silico. For now, this covers antibodies only, but it is intended to move into other modalities.

New guidance advises on assessing safety of gene editing