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Pharma channel feed
Citizen petitions: FDA revises guidance to block drugmakers from abusing the system
7 years ago
A go-go FDA is poised to break the all-time record on new drug approvals. Is this the new standard for biopharma success?
7 years ago
Special
Paratek caps 20-year R&D journey with FDA OK for its broad spectrum antibiotic — time to talk launch
7 years ago
UK alarm bells are ringing as a biotech cuts a few trial sites, fretting over Brexit’s impact on drug development
7 years ago
R&D
Gurnet Point-backed Boston Pharmaceuticals supercharges pipeline with twin deals grabbing top cast-offs from GSK, Novartis
7 years ago
Startups
Eli Lilly steers URLi toward the FDA after scoring positive results in a pair of PhIII diabetes trials
7 years ago
R&D
Giving it a GO: Giant Roche selects a tiny player at LabCentral for its next cancer R&D partner
7 years ago
R&D
Bucking the trend, Antares gains FDA OK for testosterone injection on second try
7 years ago
Insmed follows a new pathway at the FDA for antibacterials, winning quick OK for Arikayce
7 years ago
Merck’s cancer R&D juggernaut ties up to little Dragonfly’s natural born killer platform — with billions on the line
7 years ago
R&D
Ex-Kerrisdale analyst sets out to torpedo Nektar with a blunt short attack on star drug NKTR-214: 'It doesn’t work'
7 years ago
A speedy FDA offers lightning review and quick OK for the latest PD-1 from Regeneron and Sanofi
7 years ago
Pfizer nabs fast OK for a new frontline lung cancer drug as pharma giant shows off its new R&D strategy
7 years ago
Watch out Amgen and Teva, Eli Lilly got its green light for a rival CGRP migraine drug — and they’re coming after you
7 years ago
Eli Lilly picks up an oral GLP-1 diabetes drug from a big Roche sub for $50M in cash-plus deal — and it’s not a peptide
7 years ago
R&D
AMAG expands maternal health pipeline, bags late-stage orphan drug for $12.5M
7 years ago
Gilead's storied hep C franchise will now include a generic drug operation
7 years ago
Researchers point to R&D treaty to spur new infectious disease treatments
7 years ago
R&D
Unwanted by AbbVie and Infinity, battered Verastem gets an OK for duvelisib and a second shot at success
7 years ago
FDA lifts clinical hold on Sarepta's Duchenne MD gene therapy, clearing the way to a quick launch of a pivotal trial
7 years ago
FDA gives Epizyme a green light on trial recruitment, but tazemetostat isn’t completely out of the woods yet
7 years ago
Giant Amgen joins a nascent effort to build a new biotech hub in LA
7 years ago
European regulators are locking the door on Sarepta’s Duchenne drug — but they aren’t throwing away the key
7 years ago
Dismissing critical reports on patient deaths, FDA says safety/effectiveness of Nuplazid holds up under review
7 years ago
R&D
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