Amgen is refusing U.S. regulators’ request to withdraw an inflammatory disease drug. Elsewhere, Pfizer battled skepticism on new obesity drug data, and Merck laid out its post-Keytruda future.
The agency’s program will be open to pharmaceutical facilities that align with “national priorities.” Elsewhere, a ...
A long-acting shot Pfizer got through a buyout of Metsera appeared “slightly inferior” to Lilly’s market-leading Zepbound in a Phase 2 trial, one analyst said.
CagriSema’s blood sugar and weight reductions exceeded the company’s blockbuster Wegovy, yet the drug might still struggle to ...
Data integrity is key to the success of any cell therapy program. CDMOs can implement robust data management systems for ...
AstraZeneca’s investment will “span the value chain” of drug research and development and comes amid a prolonged surge in ...
Still, the medications in the latest round of negotiations — which now includes “Part B” drugs given in doctors offices — ...
On a Monday conference call, Sarepta CEO Doug Ingram said new long-term data should help “rebalance the discussion” surrounding Elevidys.
Fresh data from multiple studies suggest the drug, which Sanofi has billed as a future blockbuster, could be cleared in the U ...
A massive overhaul of staffing and review processes have left the agency appearing heavily driven by the Trump administration ...
In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a change ...
The biotech also raised $235 million in debt and equity funding to support marketing of the drop, which it claims to be an ...
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