Roche, Zealand shares fall on ‘undifferentiated’ obesity drug results

An amylin-targeting medicine at the center of the companies’ multibillion-dollar alliance spurred less weight loss than investors had hoped, leading some analysts to question its ability to stand out. 

Lilly targets employers in new bid to broaden access to obesity drugs

A service tailored to people with workplace-based insurance coverage represents a new way for Lilly to bypass insurers and expand use of its popular obesity shot. 

Blackstone puts $400M into Teva, Sanofi gut disease drug

The deal adds to a growing biotech presence for Blackstone and supports testing of a drug competing with rival therapies from Merck and Roche.

Pfizer nabs first obesity approval; Alnylam, Tenaya search for heart drugs

The clearance in China comes weeks after Pfizer acquired rights to the therapy. Elsewhere, Alnylam is looking for “novel” cardiovascular targets and investors sold off Helus shares. 

A startup making drugs for blood disorders banks $160M

Atavistik Bio is using the cash to develop “allosteric” medicines it believes can precisely impact on diseases like myelofibrosis and the blood condition HHT.

PepGen muscular dystrophy drug gets ‘surprise’ hold from FDA

The agency acted after reviewing mouse data submitted in 2024, making the timing of the new pause “confusing,” one analyst wrote.

Moderna to pay up to $2.25B to end mRNA vaccine patent fight

Announced days before a trial, the deal settles a longstanding dispute and avoids what one analyst called a “worst-case scenario” financially for Moderna.

Prime to test FDA flexibility with 2-patient gene editing submission

The planned filing comes amid heightened scrutiny of the FDA’s rare disease stance and a year after Prime deprioritized the program for economic reasons.

5 FDA decisions to watch in the first quarter of 2026

By the end of March, the agency could approve multiple “national priority” voucher winners, as well as a gene therapy it rejected two years ago.

Kyowa Kirin abandons touted eczema drug following safety review

A month after Amgen gave up on rocatinlimab — which was once seen as a threat to Dupixent — new findings have linked the drug’s mechanism to the onset of a type of skin cancer.

Pierre Fabre seeks to revive US approval chances for spurned cell therapy

Ebvallo is one of a series of rare disease treatments recently turned back by the FDA amid shifting guidance that has surprised some companies and frustrated investors.

Candid, in a reverse merger with RallyBio, to go public

Candid, which is making bispecifics for immune diseases, has also raised $505 million in a private financing for the newly formed company.

UniQure says FDA wants another study of Huntington’s gene therapy

Agency staff "strongly recommended" a sham surgery-controlled trial be conducted before an approval filing, a stance one analyst called a "worst case scenario" for UniQure.

FDA again targets GLP-1 compounders; Intellia to restart heart disease trial

The agency zeroed in on claims that compounded GLP-1 drugs are comparable to approved medicines. Elsewhere, a blood pressure drug topped Wall Street expectations and a Merck deal paid dividends.

Roche pill succeeds in another MS study, but approval questions linger

Liver-related side effects have led some analysts to question fenebrutinib’s prospects, even though the drug has now cleared Phase 3 studies in multiple forms of the disease.

Safety concerns spur Aardvark to halt key Prader-Willi drug trial

The detection of certain cardiac issues in a study of healthy volunteers led Aardvark to pause a Phase 3 trial only months before an expected data readout.

Ascendis wins FDA approval of dwarfism drug

Yuviwel, a once-weekly injection, will now compete for market share with BioMarin’s lucrative daily shot Voxzogo. 

UniQure falls further on Makary comments

Remarks the FDA commissioner made during a CNBC appearance seemed to stoke investor fears that UniQure's gene therapy for Huntington's won't get approved.

Atrium spins out of Avidity, aiming to target rare heart diseases with RNA

Four months after Avidity’s $12 billion buyout, Atrium debuted with $270 million in cash and plans to pick up its predecessor’s work in cardiovascular disease.

Generate caps a strong month for biotech IPOs with $400M offering

The AI drug discovery specialist is the fifth biotechnology company to go public in February and priced the sector’s largest new stock offering in nearly three years.

Sarepta CEO Doug Ingram to retire, with company at a crossroads

Ingram, who steered the company through multiple drug approvals and controversies, will step aside as Sarepta faces dwindling Elevidys sales and emerging competitors to its core business. 

Lilly’s GLP-1 pill tops Novo’s Rybelsus in head-to-head trial

Orforglipron, which could be approved for obesity next quarter, proved superior at cutting blood sugar and body weight — but at the expense of higher side effect rates. 

Moderna’s combination flu, COVID shot wins over European drug regulators

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for Moderna’s vaccine in the U.S. 

Boehringer drug approved in 44 days; BioMarin shelves Roctavian

Boehringer’s lung cancer medicine Hernexeos is the second “national priority” voucher winner to gain a speedy approval. Elsewhere, a landmark gene therapy was withdrawn and a Pfizer deal paid dividends.

Bristol Myers says ADC licensed from China hits mark in aggressive breast cancer

The study result is the latest step forward for a drug Bristol could eventually pay more than $8 billion for and has spotlighted as important to its future growth.