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Every briefing, headline, and filing we've published, newest first.
The WeekBriefing
Replimune won accelerated approval for Tudriqev with nivolumab in advanced melanoma after PD-1 progression. Th…
The WeekDrug Channels ↗
Today's guest post comes from Scott Filosi, Chief Commercial Officer at Valeris. Scott explores how patient ac…
The WeekPharmaceutical Technology ↗
The approval means mFlusiva becomes the first mRNA-based vaccine to be authorised on the US market for flu pre…
The WeekSTAT News ↗
"AI is not the villain here; it is a mirror," reflecting the diminishment of physician judgment, writes former…
The WeekBioPharma Dive ↗
The accelerated clearance follows two earlier rejections and the support of an advisory panel that disputed th…
The WeekPharmaVoice ↗
Schwartz will step into an agency that has been without a permanent leader for almost a year amid RFK Jr.'s tu…
The WeekPharmaVoice ↗
Reports of talks were quickly disputed, but the prospect exposed the appeal - and antitrust risks - of combini…
The WeekFiercePharma ↗
Despite a major curveball thrown by the FDA earlier this year, Moderna has managed to strike true with a U.S. …
The WeekFierceBiotech ↗
A little over a year ago, LifeMine Therapeutics laid off staff and put its fungus-based platform on ice to foc…
The WeekBriefing
Takeda won FDA approval for Orzeyful in adults with narcolepsy type 1. The decision introduces the first appro…
The WeekSTAT News ↗
Scientist-turned-biotech executive Greg Verdine is having a very good year.…
The WeekPharmaceutical Technology ↗
Reporting 91% growth for Mounjaro, Lilly widened the gap to cardiometabolic rival Novo Nordisk.…
The WeekBioPharma Dive ↗
Braveheart is one of five biotechnology firms that made plans to price an IPO this week, bringing in total wha…
The WeekPharmaVoice ↗
Global regulators are allowing the company to use hospitalization as the primary efficacy endpoint in its regi…
The WeekFiercePharma ↗
As Amgen's flagship PCSK9 cholesterol drug Repatha enjoys a bit of a renaissance on the back of impressive car…
The WeekFierceBiotech ↗
Contract research organization Icon announced a multi-year collaboration with Anthropic this week to bring Cla…
The WeekBriefing
A new analysis challenged a controversial federal-law provision that exempts certain orphan drugs from Medicar…
The WeekBriefing
STAT reported that new research found excluding rare disease therapies from a Medicare pilot program would wip…
The WeekSTAT News ↗
The Senate investigation includes RFK Jr. as well as the heads of Reynolds American and kratom company Botanic…
The WeekBioPharma Dive ↗
Despite another strong earnings report, analysts warned that upcoming cystic fibrosis data from Sionna Therape…
The WeekPharmaVoice ↗
Lilly's recent deal to acquire AtaiBeckley gave the field a boost, but other biotechs still need to prove thei…
The WeekFiercePharma ↗
In a milestone for IgA nephropathy, Otsuka's Voyxact has shown for the first time in a phase 3 trial that a dr…
The WeekFierceBiotech ↗
A phase 2 trial of Merck & Co.'s anti-TL1A monoclonal antibody has missed its primary endpoint, closing of…
The WeekBriefing
STAT said AstraZeneca stock fell after reports of merger talks with Bristol Myers Squibb. The immediate read i…
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