Ascendis Pharma A/S said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker's experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination.
said on Monday the U.S. Food & Drug Administration had declined to approve the Danish drugmaker's experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns linked to manufacturing control of the drug and device combination.
In a note on Friday, TD Cowen analyst Yaron Werber raised concerns about the lack of clarity around the FDA decision following the Ascendis' post-earnings conference late Thursday.
South Africa Latest News, South Africa Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Astellas Pharma buys Iveric Bio for $5.9 billionJapan's Astellas Pharma said on Monday it agreed to buy U.S.-based drugmaker IVERIC Bio Inc for about $5.9 billion in its biggest acquisition, giving it access to a range of ophthalmology treatments.
Read more »
Breast implants tied to rare cancer to remain on U.S. marketThere have been more than 600 of these cancer cases worldwide, but the FDA decided against a ban
Read more »
Celebrating National Minority Health Month with Dr. Namandjé BumpusDr. Namandjé Bumpus, Chief Scientist of the FDA, has been a first in almost everything she’s done. But for her, success will mean that she’s not the last. See how she’s breaking glass ceilings for those who are underrepresented in science at WeCanDoThis
Read more »
Eli Lilly seeks FDA approval for diabetes drug to be used for weight lossPharmaceutical company Eli Lilly is pushing for FDA approval for Tirzepatide, a medication used to help control blood sugar for type-2 diabetics, to be used for another purpose: weight loss.
Read more »
FDA issues strong warning over risks of common sleeping pillsSome prescription sleeping pills like Ambien and Lunesta will now come with a prominent warning slapped on the box
Read more »