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FDA approval comes early for Regeneron's Eylea in DME

 
• By Mandy Jackson

US FDA approval was granted three weeks early for the Regeneron Pharmaceuticals vascular endothelial growth factor (VEGF) inhibitor Eylea (aflibercept) in the treatment of diabetic macular edema (DME), broadening the blockbuster biologic's label beyond its first two indications.

US FDA approval was granted three weeks early for the Regeneron Pharmaceuticals vascular endothelial growth factor (VEGF) inhibitor Eylea (aflibercept) in the treatment of diabetic macular edema (DME), broadening the blockbuster biologic's label beyond its first two indications.

Tarrytown, New York-based Regeneron may add a fourth indication before year-end, since the FDA is expected to decide on a...

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Altimmune’s Phase IIb MASH Data Send Share Price Plunging

 
• By Joseph Haas

Altimmune’s stock price did not recover on June 27, after a 57% dip the day before, despite efforts to position pemvidutide as both resolving MASH and offering weight loss.

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By Aakash Babu

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

Battle For Obesity Market Shifts Gears in India: Will Wegovy Trump Mounjaro?

 
• By Anju Ghangurde

Novo Nordisk debuts Wegovy in India, gears for pole position in obesity. The Danish group’s leadership doesn’t appear too perturbed about the head start for Lilly’s Mounjaro or the imminent arrival of generic semaglutide next year.

Amgen’s MariTide Data Not The Hit Investors Sought

 
• By Joseph Haas

MariTide demonstrated solid 52-week weight loss in a Phase II update, but high rates of vomiting. Amgen is adjusting dosing in Phase III to seek a better tolerability profile.

More from Therapy Areas

Veru’s Enobosarm Market Potential Enhanced By New Obesity Data

 
• By Aakash Babu

The late-stage biotech posted results from the maintenance extension portion of its Phase IIb QUALITY trial in which enobosarm reduced weight regain and helped preserve lean mass in patients who discontinued their semaglutide weight-loss treatment.

GSK, Bharat On Shigella Vaccine Phase II Data Timelines, Malaria Vaccine Price Halving

 
• By Vibha Ravi

GSK tells Scrip about timelines for data expected from two Phase II trials for its Bharat Biotech-partnered shigella vaccine candidate, which puts it ahead of Limmatech/Valneva. Meanwhile, a global-first malaria vaccine, also partnered with Bharat, sees an over 50% price cut

Pfizer’s Hympavzi Poised For Broader Hemophilia Label

 
• By Alaric DeArment

The drugmaker announced positive topline results for the drug in hemophilia A and B patients with inhibitors, on top of the existing approval for patients without inhibitors.