Sanofi top-lined positive clinical data today from its investigational basal insulin, as it seeks to defend its position in this fast-growing segment.
The drugmaker says interim trial data meets FDA review requirements and is hoping for June 2014 approval.
New results from its Phase II safety trial show the LDL-cholesterol lowerer was not associated with a major increase in adverse events vs. standard of care.
An investigational cardiovascular heart drug failed to reduce the risk of heart attack or stroke, a miss which some on Wall Street say raises questions about the drugmaker's ability to deliver in late-stage trials.
Safety reviewers' reservations about the MS drug's risk profile, unveiled in briefing documents ahead of an ad-com meeting, suggest it won't be smooth sailing for the drug in the US.
The drugmaker blasted the price-control agency for being shortsighted and underestimating the industry's role in health and savings.
The drug company is ceasing US distribution and marketing the leukemia drug after the FDA said it was worried about blood clots among clinical trial patients.
The FDA told the drugmaker in a letter before the December PDUFA date that evidence does not support an expanded indication.
The AAP says greater access and education are critical in curbing STIs.
The hep. C drug is safe and effective when used in combination with other therapies, according to information posted by FDA reviewers.
Word came of Breakthrough Designation for an HCV hopeful, a day after a hiccup in a heart drug trial.
A report says oncologists may be using GSK's Tafinlar and Mekinist together in a non-FDA approved combination therapy.
Adding Epzicom to Tivicay in a once-daily cocktail could further boost GSK's HIV franchise, and possibly chip away at Atripla's dominance.
On Monday Regeneron reported more positive Ph. III data for its wet AMD/macular edema drug Eylea (aflibercept).
Lantus-like rivals can expect a wary reception from endocrinologists, even if these biosimilars reach market, researchers predict.
The agency says the copycat antidepressant failed to meet bioequivalency requirements.
In schizophrenia, non-compliance can be disastrous. Do depot drugs really make a difference for patients?
An analyst notes that early Phase III results in a psoriasis clinical trial could change the drug's efficacy profile. It could also fill out the financial potential of a standalone innovative unit, should Pfizer divide.
The drug maker says a patient's physician did not link the MS drug to her death.
The drug maker says it is accelerating development of new drugs and focusing on expanding indications of current ones.
Recent studies underscore a need for greater engagement in multicultural communities.
Monday's announcement builds on a stream of recent R&D relationships.
A public information request details closed-door meetings in which industry players paid to sit with government employees and talk pain-medication efforts.
Researches say cognitive enhancers, a group which includes drugs like Aricept and Exelon, fail to slow decline in patients with Alzheimer's over the long term.
Eli Lilly is the first Big Pharma to team up with the agency in its rare-disease pre-clinical development program.
GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.
Bristol-Myers Squibb said Thursday that the drug failed to hit its primary goal in a prostate cancer trial, but some analysts say the data is not the last word on its potential in this tumor type.
The advisory panel endorsed the treatment with an 11-2 vote.
The changes, which include tightening prescribing criteria of extended-release and long-acting opioids and a boxed warning for pregnancy, are part of an effort to curb abuse. Some said the FDA's effort is too limited
The experimental LAMA/LABA combination could shake up the category.