Abecma and cilta cel are part of an emerging class of multiple myeloma treatments that target a protein called BCMA, which is found on cancer …
Amylyx Pharmaceuticals has officially asked the Food and Drug Administration to approve its experimental and closely watched medicine for ALS. Now, the FDA has around …
U.K. regulators have once again moved faster than the Food and Drug Administration to approve a new medicine for COVID-19. The UK’s Medicines and Healthcare …
A group of advisers to the Food and Drug Administration on Tuesday endorsed use of Pfizer’s coronavirus vaccine in younger children, judging the benefits of …
With few treatment options and millions of patients in the U.S. alone, Alzheimer’s has long been one of the biggest targets for drug developers. Yet, …
Merck’s pill has the potential to alter the course of the pandemic. Earlier this month, the company and partner Ridgeback Biotherapeutics released data showing molnupiravir …
This is the first time government advisers have recommended routine use of a pneumococcal vaccine for certain risk groups within the 19-64 age bracket, a …
The new label opens up a significant market opportunity for Lilly, as about 70% of people diagnosed with breast cancer have the hormone receptor positive, …
Merck’s Keytruda is the dominant cancer immunotherapy and, of the seven of its type that are approved, the only that’s cleared for use in cervical …
For the past several months, one of the many questions hanging over the booster debate has ben what do with people who got J&J’s shot. …
The FDA has been under pressure to review the status of drugs granted accelerated approvals based on early data, as in some cases confirmatory trials …
While the clinical hold lifting is encouraging news for the companies’ partnership, questions still loom about safety in the genetic medicine field. Earlier this month, …
Peter Marks, one of the Food and Drug Administration’s top-ranking officials, has taken over the agency’s vaccine review office just as the regulator begins considering …
In the midst of a years-long makeover, Takeda is looking to new products such as Exkivity to shore up future growth and cement its place …
Galapagos looked to be in a strong position at the start of 2020. It had recently closed a major research deal with Gilead that not …
The Food and Drug Administration on Monday granted full approval to Pfizer and BioNTech’s coronavirus vaccine, a long-awaited decision that government officials hope could help …
Should detailed study results bear out ALXN1480’s benefit and lead to an FDA approval, the experimental drug could become an important new option for people …
Rocket’s program has been in limbo since early May, when the company surprised investors and analysts with news of the trial’s stoppage. That announcement stalled …
The U.S. health department’s inspector general will review how the Food and Drug Administration grants accelerated approvals of new drugs, announcing a broad investigation Wednesday …
The promise of biosimilars — that competition would bring down the prices of complex biological drugs — hasn’t materialized in the U.S. in the way …
