Tag: FDA
Novo Nordisk: indication extended by the FDA for Wegovy
(CercleFinance.com) – The Danish pharmaceutical company Novo Nordisk announces that the United States FDA has extended the indication of its flagship drug Wegovy for the reduction of the risks of…
Novo Nordisk: Indication extended by the FDA for Wegovy
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Eli Lilly: The American FDA postpones its decision on a treatment for Alzheimer’s
(Reuters) – The U.S. Food and Drug Administration (FDA) has postponed by several months the announcement of its opinion on donanemab, an experimental treatment for patients with early-stage Alzheimer’s disease,…
Eli Lilly: FDA meeting on donanemab in Alzheimer’s
(CercleFinance.com) – Eli Lilly reports that the US Food and Drug Administration (FDA) plans to convene a meeting of the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee to…
Carbios: FDA approval for Carbios Active – 03/05/2024 at 2:35 p.m.
(CercleFinance.com) – The biotechnology company Carbios announces that Carbios Active, its enzymatic solution for the biodegradation of PLA, is included in the United States FDA’s inventory of food contact substances…
US FDA authorizes new claim that yogurt may reduce diabetes risk – 03/01/2024 at 7:24 p.m.
((Automated translation by Reuters, please see disclaimer https://bit.ly/rtrsauto)) (Adds market share data, clarifies that Danone North America has filed with the FDA, and corrects Blechman’s name) by Jessica DiNapoli The…
Sanofi: FDA grants priority review to Dupixent for COPD – 02/23/2024 at 09:41
(AOF) – Sanofi announces that the FDA grants priority review to the biologics license application for Dupixent for the treatment of chronic obstructive pulmonary disease (COPD) with type 2 inflammation.…
AstraZeneca: FDA approves Tagrisso against lung cancer – 02/19/2024 at 11:06
(AOF) – AstraZeneca announces that its product Tagrisso (osimertinib) combined with chemotherapy has been approved in the United States for the treatment of adult patients with locally advanced or metastatic…
Roche: FDA approves treatment for allergies
(CercleFinance.com) – The group announces that the FDA has approved Xolair as the first and only drug intended for children and adults suffering from one or more food allergies. The…
Ipsen: FDA approval for the therapeutic regimen including Onivyde, a potential new first-line reference treatment in metastatic pancreatic adenocarcinoma
By Claude Leguilloux Published on 02/14/2024 at 7:27 a.m. (Boursier.com) — Ipsen announces that the American authorities (Food…
TME Pharma: success against brain cancer, a file submitted to the FDA – 02/02/2024 at 09:44
(AOF) – TME Pharma announces that the final median overall survival for patients with recently diagnosed glioblastoma (brain cancer) treated with its product NOX-A12 has reached 19.9 months. The biotech…
Bristol Myers: 2 FDA priority reviews for Breyanzi
(CercleFinance.com) – Bristol Myers Squibb indicates that health authorities have agreed to examine three regulatory applications relating to Breyanzi (lisocabtagene maraleucel): two applications have been accepted by the Food and…