Gilead recently announced that FDA approved Trodelvy for adults with unresectable, locally advanced, or metastatic triple-negative breast cancer (TNBC).
FDA based its approval on results from a Phase...
The Federal Trade Commission (FTC) recently filed an administrative complaint and authorized a federal court lawsuit to block Illumina’s $7.1 million pharma acquisition deal of cancer detection...
The Biden Administration recently released new prescription drug policy priorities that focus on addressing the opioid epidemic and reducing drug overdoses.
The priorities provide guideposts to...
The Biden Administration recently appointed Johnson & Johnson to lead COVID-19 vaccine production at a Baltimore manufacturing plant that contaminated 15 million doses of the pharmaceutical...
FDA recently announced two revisions regarding the number of doses per vial available for Moderna’s COVID-19 vaccine, mRNA-1273.
The agency’s first revision clarifies the number of doses...
FDA recently approved Abecma, the first cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after previous...
FDA recently granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1) COVID-19 diagnostic test.
BioFire RP2.1 is used for the simultaneous qualitative detection of multiple...
FDA recently issued an emergency use authorization for an at-home and over-the-counter (OTC) COVID-19 diagnostic test.
The Cue COVID-19 Test for Home and OTC Use test is a molecular nucleic acid...
FDA recently approved G1 Therapeutics’ Cosela a therapy intended to reduce the frequency of chemotherapy-induced bone marrow suppression in adults for extensive-stage small-cell lung...
HHS recently announced new actions to expand COVID-19 testing capacity across the US as part of President Joe Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness.
The...
HHS recently issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add categories of qualified persons authorized to prescribe,...
President Joe Biden recently signed an executive order to combat COVID-19 and prepare for future biological and pandemic threats.
“The Federal Government must act swiftly and aggressively...
Janet Woodcock will be stepping in as Acting FDA Commissioner while the Biden administration finalizes a nominee for the position.
Woodcock will replace Stephen M. Hahn, MD, after he resigned last...
Moderna recently announced that the European Commission (EU) granted conditional marketing authorization (CMA) for its mRNA COVID-19 vaccine.
The authorization of COVID-19 Vaccine Moderna,...
AstraZeneca recently announced that its COVID-19 vaccine has been granted emergency use authorization in India, Argentina, Dominican Republic, El Salvador, Mexico, and Morocco.
The authorization of...
AstraZeneca recently announced that its COVID-19 vaccine has been approved for emergency supply in the United Kingdom (UK).
This is the first emergency authorization for COVID-19 Vaccine...
GSK recently announced that FDA approved BENLYSTA (belimumab) as the first chronic disease treatment for adult patients with lupus nephritis (LN), who are receiving standard...
California Governor Gavin Newsom recently launched a campaign for safe, fair, and equitable distribution of a COVID-19 vaccine in all 58 counties of the state.
The “Vaccinate All 58”...
HHS recently announced that the CDC will award an additional $227 million for COVID-19 vaccine preparedness and response activities.
Specifically, $140 million will be used for vaccine preparedness...
The Supreme Court unanimously ruled that US states can regulate pharmacy benefit managers.
The decision released at the beginning of December ruled in favor of groups arguing on behalf of...
