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FDA approves Merck's Keytruda as first immunotherapy for early kidney cancer

Immune-boosting drugs like Keytruda are increasingly being tested, and proven effective, alongside surgery before tumors spread widely.

European drugs regulator signals rejection likely for Biogen's Aduhelm

A European Medicines Agency panel tasked with reviewing drugs voted against the biotech's controversial Alzheimer's medicine, signaling an approval is unlikely next month.

Roche cuts ties with Atea after COVID-19 pill's trial failure

The Boston biotech, shares of which soared last year on hopes for the antiviral drug, said it has plenty of money to advance development on its own.

Al Sandrock, Biogen's top scientist and Aduhelm defender, to retire in surprise exit

Sandrock championed the controversial Alzheimer's drug, and was integral to the development of several other of Biogen's most important medicines during his 24 years at the biotech. 

Pfizer asks FDA to authorize COVID-19 pill

Study results released this month showed the pill, when given soon after symptoms start, sharply reduced the risk of COVID-19 hospitalization or death.

As Congress weighs drug price restraints, ICER calls out 'unsupported' increases

In a new report, ICER highlighted AbbVie's price hikes on Humira, which the group said resulted in more than $1 billion in U.S. spending last year without any new evidence of health benefits.

A startup emerges with $125M and plans to edit the epigenome

Chroma Medicine's launch is the latest step in a decadeslong quest by drugmakers to capitalize on research into epigenetics, a way of controlling gene expression without altering DNA.

Pfizer will allow generic drugmakers to produce promising COVID-19 pill

A licensing deal with a U.N.-backed patent group could expand supply of Pfizer's experimental drug Paxlovid in lower- and middle-income countries.

Years later, a first-of-its-kind treatment shows the power, and limits, of gene therapy

Luxturna, approved four years ago as the first gene therapy for an inherited disease in the U.S., is improving sight and quality of life for several of the patients who received it.

Anticipating Aduhelm's costs, Medicare plans big jump in premiums

While CMS is still weighing whether to authorize wide coverage of Biogen's pricey Alzheimer's drug, administrators are planning to build reserves in case costs skyrocket.

Biden nominates Robert Califf to return as FDA head

If confirmed by Congress, the cardiologist would return to lead an agency facing weighty questions on COVID-19, a new user fee agreement and department staffing. 

Updated Nov. 12, 2021

J&J, world's largest drugmaker, plans to split in two

The industry giant and mainstay of corporate America will separate its consumer health business from its drug and medical device units, which will retain the J&J brand. 

Updated Nov. 12, 2021

Cortexyme plans path forward for Alzheimer's drug that failed study

Detailed trial results presented last week are "interesting," one Alzheimer's expert said, but there are still "many challenges and uncertainties" with Cortexyme's unorthodox approach to treating the disease.

Detailed Roche study results muddy another Alzheimer's hypothesis

Data presented at an Alzheimer's meeting raised more questions about the seeming benefit of Roche and AC Immune's drug semorinemab, which they claim is the first of its kind to slow deterioration of memory.

Moderna, escalating dispute with NIH, claims government had no role in key vaccine patent

The biotech claimed its NIH partners were involved only after a key discovery was made "by Moderna scientists using Moderna technology." The dispute could end up in court.

FibroGen cuts jobs as it weighs anemia drug's future in US

The company, which had its treatment rejected by the FDA in August, eliminated 30 jobs and 70 open positions. An upcoming meeting with the agency looms as a key event.

Moderna founder unveils new drug company focused on a different kind of RNA

Encouraged by Moderna's success, Flagship Pioneering has been busy creating startups like Alltrna, which launched Tuesday. The biotech is researching how to make medicines from transfer RNA molecules.

Pfizer buys into Biohaven's fast-selling migraine medicine

The pharmaceutical giant will pay Biohaven $500 million for ex-U.S. rights to rimegepant — a sizable licensing deal, though not the buyout that some of the biotech's investors appeared to be hoping for.

Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk of COVID-19. 

US pays $1B to nearly double supply of Merck's COVID-19 pill

The new agreement raises the financial upside of molnupiravir, which Merck believes could be a $7 billion product in 2022. But Pfizer's rival drug, which is seemingly more effective, could affect those projections.

Mirati gives first look at KRAS drug combination in lung cancer

Study results for Mirati's drug combined with Keytruda have been much anticipated, as the San Diego biotech aims to challenge Amgen and its rival KRAS-blocking drug Lumakras.

Updated Nov. 8, 2021

Beam gets green light to begin first clinical test of base editing

Alongside the milestone, the gene editing biotech also announced John Maraganore, who will soon step down as Alnylam's CEO, will join its board.

Eye-focused gene therapy startup gets $60M cash infusion from Sanofi

Shortly after postponing a $135 million IPO, Gyroscope has found another way to back a treatment for a disease that's become a top target of multiple drugmakers.  

Blackstone continues biotech push with up to $250M cell therapy investment

The investment in CAR-T maker Autolus Therapeutics adds to a string of biotech deals the private equity firm has made since 2018.

Pfizer pill for COVID-19 shows dramatic benefit in major study finding

The drugmaker, which on Oct. 29 won FDA clearance of its vaccine in younger children, plans to quickly ask the agency for emergency authorization of the drug in high-risk patients.