MedPage Today2d
FDA Rejects Full Approval of Liver Disease Drug
Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...
Medscape1mon
FDA Approves Fifth Ustekinumab Biosimilar
The US Food and Drug Administration (FDA) has approved ustekinumab-srlf (Imuldosa) as a biosimilar to ustekinumab (Stelara) for the treatment of multiple inflammatory conditions. This is the fifth ...
FiercePharma1d
FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
pharmaphorum2d
FDA's Duchenne drug approval greeted with joy, but remains controversial
After months of uncertainty and controversy, the FDA has given approval to Sarepta's Duchenne muscular dystrophy drug – even though it hasn't yet shown any proof it can slow progress of the ...
Reuters8h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
Nov 13 (Reuters) - The U.S. Food and Drug Administration approved PTC Therapeutics' (PTCT.O), opens new tab gene therapy that ...
dvm3601d
FDA approves renewal for canine chemotherapy-induced diarrhea treatment
Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved ...
Medical Xpress1mon
FDA approves Hympavzi for hemophilia
The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ...
USA Today27d
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The Food and Drug Administration approved a drug produced by AbbVie for the treatment of late stage Parkinsons disease the company announced Thursday. The regulator approved Vyalev, also known as ...
Fox News29d
Experimental ALS drug could offer new hope for patients if approved, researchers say
New hope could be on the horizon for ALS patients in the form of a "breakthrough" drug, researchers say. Neuvivo, a California biopharmaceutical company that develops therapies for ...
Reuters26d
FDA approves Astellas' gastric cancer therapy
Oct 18 (Reuters) - The U.S. Food and Drug Administration approved Astellas' (4503.T), opens new tab therapy to treat a type of gastric cancer, the health regulator's website showed on Friday.
Yahoo Finance27d
FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment
The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic ...
Yahoo Finance27d
Avadel wins FDA approval for narcolepsy drug Lumryz in children
after the US Food and Drug Administration (FDA) approved a supplemental new drug application. The expanded approval for the oral suspension is for the treatment of sudden muscle weakness ...