Edition:
United States

Trisha Roy

Lexicon Pharma shares plummet after FDA denies appeal against drug rejection

Dec 02 2019

The U.S. FDA denied Lexicon Pharmaceuticals Inc's appeal against the rejection of its add-on treatment for type 1 diabetes, marking the company's third major setback this year and sending its shares plunging 18% on Monday.

FDA approves Global Blood Therapeutics sickle cell disease drug

Nov 25 2019

The U.S. Food and Drug Administration said on Monday it approved a drug from Global Blood Therapeutics Inc to treat sickle cell disease in adults and children 12 years or older.

Alnylam's rare genetic disorder drug priced at $575,000 per year

Nov 20 2019

Alnylam Pharmaceuticals Inc priced its gene silencing drug to treat patients with a rare genetic disorder that can cause severe pain at $575,000 per year after receiving an early U.S. approval on Wednesday.

FDA panel unanimously backs expanding use of Amarin's heart drug Vascepa

Nov 14 2019

A panel of experts to the U.S. FDA recommended allowing Amarin Corp Plc's fish-oil derived drug to be used as an add-on therapy for reducing the chance of heart attacks and strokes in high-risk patients with cardiovascular disease.

FDA panel votes against Lilly-Boehringer Ingelheim's diabetes drug

Nov 13 2019

Independent experts on an FDA advisory panel on Wednesday voted against the use of an already approved diabetes drug from Eli Lilly and Co and Boehringer Ingelheim as an add-on to insulin therapy in patients with type 1 diabetes.

SmileDirectClub sees more losses for the year; shares slump

Nov 12 2019

SmileDirectClub Inc , in its first results since going public in September, reported a bigger quarterly loss on Tuesday as expenses rose and the teeth alignment company pointed toward more losses for the year.

Celgene's drug for anemia in beta thalassemia priced at $3,441/ 25 mg vial

Nov 08 2019

Celgene Corp's treatment for anemia in patients with beta thalassemia, a rare blood disorder, would be priced at $3,441 for a 25-milligram vial of the drug, partner Acceleron Pharma Inc said.

Eylea powers Regeneron's third-quarter profit beat; shares rise

Nov 05 2019

Drugmaker Regeneron Pharmaceuticals Inc beat analysts' estimates for third-quarter profit on Tuesday, boosted by higher demand for its blockbuster eye drug, Eylea, and eczema therapy Dupixent.

Small relief for Biogen in MS drug approval

Oct 30 2019

The U.S. Food and Drug Administration on Wednesday approved Biogen Inc's new oral drug to treat multiple sclerosis, offering the drugmaker some relief as its core franchise faces patent challenges.

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