News

Enrollment Initiated in Jaguar Health Study of its FDA Conditionally Approved Canalevia-CA1 Prescription Drug for Dogs
In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...
Fierce Biotech1h
'Crossing fingers': Boehringer awaits key FDA decisions to spearhead 'maturing' pipeline
It's shaping up to be a big year for Boehringer Ingelheim—at least if the FDA plays ball. | Boehringer Chief Medical Officer ...
The FDA Just Approved Another Natural Food Dye for Use in Several Common Snacks and Drinks
According to today's announcement from the FDA, an estimated 40% of the food industry has committed to voluntarily phasing ...
FDA Suspends Muscular Dystrophy Drug After 3 Patient Deaths
The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...
GlobalData on MSN5d
GSK’s Blenrep faces setback as FDA cancer committee votes against approval
Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab mafodotin) ...
Health Rounds: Experimental Bayer drug eases menopause-like symptoms from breast cancer therapy
The hot flashes and night sweats that plague breast cancer survivors during years-long hormone-suppressing therapy are eased ...
GSK falls as FDA advisors vote against approving blood cancer drug
GSK (GSK) stock slips as FDA advisors vote against the approval of a combination regimen involving thecompany's blood cancer drug Blenrep. Read more here.
Fierce Pharma5d
FDA mulls Elevidys market withdrawal following 3rd death after a Sarepta gene therapy
Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—a market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...
Ohio lawmakers push to restore state employee access to Ozempic, weight loss drugs
Lawmakers are trying to restore access to GLP-1 weight loss drugs, like Ozempic and Wegovy, after Ohio removed medical ...
BioWorld5d
In an adcom on Otsuka’s PTSD drug, FDA wants more data
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a ...
CURE5d
FDA Votes Against Proposed Blenrep Treatment Combo’s for Multiple Myeloma
The FDA's Oncologic Drugs Advisory Committee has casted their votes on the utilization of certain treatments in the multiple ...