Becoming the second oral weight-loss glucagon-like peptide-1 (GLP-1) receptor agonist to reach the U.S. market, and the first new molecular entity cleared under the FDA Commisioner’s National Priority Review (CNPV) pilot program, Eli Lilly and Co.’s orforglipron, branded Foundayo, won approval for use in combination with a reduced-calorie diet and increased physical activity to treat adults with obesity or who are overweight with medical problems. It will be available beginning April 6 through Lilly’s direct-to-consumer marketing platform. The approval came nearly 10 months ahead of the Jan. 20, 2027, PDUFA date, and 50 days following its regulatory filing, within the two-month expected timeframe laid out in the CNPV program. Novo Nordisk A/S gained FDA approval of an oral version of Wegovy (semaglutide) in December.

Korsana boosts Alzheimer’s work with reverse merger, $380M financing

A month after emerging from stealth with a $150 million series A, Korsana Biosciences Inc. is making the leap to the public market via a merger with Cyclerion Therapeutics Inc. The agreement, which is backed by a $370 million private placement from Korsana’s investors, solidly positions the newly merged company as it heads toward the clinic with KRSA-028, a next-generation shuttled antibody targeting amyloid beta for the treatment of Alzheimer’s disease, and builds out a pipeline of neurodegenerative disease candidates. For Cyclerion, which has reinvented itself more than once following its 2019 spinout from Ironwood Pharmaceuticals Inc., the news received a positive endorsement on the Street, with shares (NASDAQ:CYCN) trading up 300% at midday.

US FDA warns of liver injuries, deaths associated with Tavneos

Once again, Amgen Inc.’s Tavneos (avacopan) is under the U.S. FDA’s scrutiny, as the agency yesterday alerted patients and doctors about drug-induced liver injury, including deaths, associated with the drug. Developed by Chemocentryx Inc., Tavneos was approved in 2021 as adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis in combination with standard therapy. Just a few months ago, the FDA asked Amgen, which acquired Chemocentryx in 2022, to voluntarily withdraw Tavneos from the market due to concerns about the process Chemocentryx used to re-adjudicate primary endpoint results for nine of the 331 patients in the drug’s pivotal trial. Surprised by the request, Amgen said no, but promised to work with the agency to address concerns.

DM1 space mulling Pepgen’s latest phase II data

Investors continue to digest Pepgen Inc.’s data in myotonic dystrophy type 1 (DM1) from the 5-mg/kg multiple ascending dose cohort of the ongoing phase II Freedom2-DM1 trial. The Boston-based firm said that the totality of safety and efficacy results support the potential of the 10-mg/kg dose cohort, for which results expected in the second half of this year. As Wall Street weighed the findings disclosed March 31 against those of competitors, Pepgen shares (NASDAQ:PEPG) fell from $4.23 to $1.43. The stock was trading at $1.81 today, up 7 cents.

Med-tech players join efforts to tackle PAD amputations in the UK

With cases of peripheral artery disease (PAD) rising across the U.K. and lower limb amputations continuing to increase, med-tech companies joined forces with parliamentarians and health care professionals to push for urgent reform of the vascular sector. Despite progress in cardiac and stroke care, as well as new technologies, thousands of major lower-limb amputations happen each year. A new white paper proposes a number of measures to reform the sector centered on a community-first model of vascular care which will deliver earlier diagnosis, better outcomes and greater efficiency.

Five-drug VIPOR regimen shows promise in aggressive blood cancer

Deep molecular advances are enabling precision medicine for the field of hematology, Wyndham Wilson said during a plenary session at the 2026 Korean Society of Hematology International Conference (ICKSH 2026) March 26. Wilson recalled that chemotherapy was the standard treatment for decades, including R-CHOP to treat diffuse large B-cell lymphoma. “Around 30% to 40% are not cured with up-front chemotherapy — and let me just say that this is not really an accurate number,” he said. “The real number is lower,” considering the data only reflected patients well enough to participate in clinical studies. At the National Cancer Institute, Wilson co-led the development of VIPOR, a five-drug chemotherapy-free combination that has shown remarkable success in patients who have failed all other treatments, including CAR T therapy.

Wegovy pricing deal offers UK reimbursement for heart disease

Novo Nordisk A/S’ Wegovy (semaglutide) has passed the notoriously strict cost-effectiveness scrutiny of the U.K. health technology assessment body and will now be reimbursed for the prevention of further serious cardiovascular events in people who have had a heart attack or stroke, or are diagnosed with peripheral arterial disease. The National Institute of Health and Care Excellence says anyone at high risk of another serious cardiovascular event and who is overweight – with a body mass index of 27 or more – should get access to Wegovy.

Trade secret theft results in loss of US citizenship

On top of prison sentences, loss of assets and a $2.6 million restitution order issued several years ago, Li Chen and Yu Zhou had their naturalized U.S. citizenship revoked Monday as a consequence of stealing exosome-related trade secrets from Nationwide Children's Hospital's Research Institute in Ohio – the hospital that had sponsored them when they first came to the U.S. from China on H-1B Specialty Occupation visas. The revocation was based on the couple’s guilty pleas, in 2020 and 2021, to one count each of conspiracy to commit theft of trade secrets and conspiracy to commit wire fraud. A federal judge found that the crimes involved moral turpitude that prevented Chen and Zhou from having the good moral character necessary to naturalize.

Also in the news

Agios, Ambrosia, Ascendis, Astrazeneca, Concept, Cytovale, Diagens, Elevar, Fortress, Guided, Haemonetics, Immunitybio, Immunic, Infinimmune, Inogen, Kalohexis, Leo, Lipella, Medibeacon, Merck & Co., Mindmaze, Natera, Novo, Oculis, Onconetix, Oric, Palisade, Pepgen, Polypid, Poxel, Praxis, Proxygen, Reset Health, Sanofi, Scholar Rock, Science Corp., Scynexis, Soundable Health, Stryker, Sub‑Q Bionics, Takeda, Telo Genomics, Tippingpoint, Vibra, Volitionrx