Pharmaceutical
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Amneal gets FDA warning letter tied to prior recalls of antibacterial products
The FDA issued a warning letter to Amneal Pharmaceuticals criticizing the drugmaker for failing to correct problems that led to a string of recalls of...
ImmunoPrecise evolves into MindWalk to reflect AI-focused future
ImmunoPrecise Antibodies has cemented a recent shift in its focus by adopting a new name: MindWalk. The new brand, which also covers the company’s Bio...
FDA's Vinay Prasad floats controlled trial requirements for vaccine coadministration claims
Citing a “new evidenced based philosophy,” the FDA’s Center for Biologics Evaluation and Research (CBER) is preparing to take a hard line against the...
CDC papers identify 7 potential ACIP nominees, including 3 who have questioned COVID vaccines: reports
Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has selected seven new experts that he plans to nominate to the Advisory...
Gilead urges people living with HIV to 'Choose U' in campaign touting long-term treatment success
As the annual U.S. Conference on HIV/AIDS (USCHA) kicks off in Washington, D.C., this week with a focus on aging with HIV, Gilead Sciences is rolling...
FDA moves to publish drug rejection letters in real time, releases new batch including Replimune’s high-profile snub
The Food and Drug Administration today announced a plan to publicly release complete response letters at the same time they are issued to sponsoring c...
RFK Jr. blasts pharma industry, touts mRNA misinformation in heated Senate hearing
During a tense and at times incendiary senate hearing Thursday, Robert F. Kennedy Jr. blamed the pharmaceutical industry and fell back on vaccine misi...
A drug discovery startup banks $150M for immune and obesity drugs
Dive Brief: Enveda Biosciences said Thursday it raised $150 million in Series D financing, doubling the cash it’s pulled in from venture capitalists t...
Sanofi’s touted eczema drug hits study goal, but data fall short of expectations
Dive Brief: Sanofi shares dropped after the French drugmaker reported results from a highly anticipated study of a new kind of medicine for eczema tha...
FDA outlines new review pathway for drugs treating ultra-rare diseases
Dive Brief: The Food and Drug Administration plans to work more closely and flexibly with developers of drugs for certain ultra-rare conditions, outli...
Amneal gets FDA warning letter tied to prior recalls of antibacterial products
ImmunoPrecise evolves into MindWalk to reflect AI-focused future
FDA's Vinay Prasad floats controlled trial requirements for vaccine coadministration claims
CDC papers identify 7 potential ACIP nominees, including 3 who have questioned COVID vaccines: reports
Gilead urges people living with HIV to 'Choose U' in campaign touting long-term treatment success
FDA moves to publish drug rejection letters in real time, releases new batch including Replimune’s high-profile snub
RFK Jr. blasts pharma industry, touts mRNA misinformation in heated Senate hearing
A drug discovery startup banks $150M for immune and obesity drugs
Sanofi’s touted eczema drug hits study goal, but data fall short of expectations
FDA outlines new review pathway for drugs treating ultra-rare diseases
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