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Fda
Business / FinanceBy Rtt News2023-10-17 13:07:30
(RTTNews) - Minerva Neurosciences, Inc. (NERV) has received a refusal to file letter from the FDA regarding the New Drug Application for roluperidone for the...
Business / FinanceBy Rtt News2023-10-17 11:42:41
(RTTNews) - Biogen Inc. (BIIB) announced the FDA has extended the review period of the NDA for tofersen by three months. The updated PDUFA goal date is April...
Business / FinanceBy Rtt News2023-09-28 05:17:06
(RTTNews) - Dutch biopharmaceutical company Pharming Group N.V. (PHAR) announced that the US Food and Drug Administration has accepted for priority review...
MarketsBy Zacks2023-10-17 16:52:00
Shares of Reata Pharmaceuticals RETA increased 20.6% on Oct 14 on investors optimism about the FDAs decision not to hold an advisory committee (AdCom)...
MarketsBy Rtt News2023-10-21 11:50:27
(RTTNews) - The U.S. Food and Drug Administration has accepted for review ARS Pharmaceuticals, Inc.'s New Drug Application (NDA) for neffy for the emergency...
MarketsBy Zacks2024-09-13 12:44:00
Acadia Pharmaceuticals Inc. ACAD announced that the FDA has accepted for review its new drug application (NDA) seeking approval of its pipeline candidate,...
Business / FinanceBy Globe Newswire2023-10-27 05:00:00
Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, and Rockville, MD, USA, October 2 7, 202 2 Santhera Pharmaceuticals (SIX: SANN) and...
Business / FinanceBy Business Wire2023-10-21 11:31:00
neffy has potential to be the first non-injectable medicine indicated to treat allergic reactions (type I) including anaphylaxis in the U.S., if approved...
Business / FinanceBy Rtt News2023-10-14 02:47:46
(RTTNews) - The U.S. Food and Drug Administration has informed Reata Pharmaceuticals Inc. (RETA) that it does not plan to hold an advisory committee meeting...
Business / FinanceBy Business Wire2023-10-21 11:30:00
neffy has potential to be the first non-injectable medicine indicated to treat allergic reactions (type I) including anaphylaxis in the U.S., if approved ARS...
Business / FinanceBy Rtt News2023-10-06 11:30:32
(RTTNews) - Entera Bio Ltd. (ENTX), a developer orally delivered peptides and therapeutic proteins, announced Thursday the successful conclusion of its Type...
MarketsBy The Editorial Board2024-09-21 22:38:00
An agency report blames its failures onwait for itlack of money.
Press Release2024-09-20 12:30:00
Carson City, Nevada--(Newsfile Corp. - September 20, 2024) - Cell MedX Corp. (OTC PINK: CMXC) ("Cell MedX" or the "Company"), a biotech company focusing on...
Business / FinanceBy Rtt News Staff Writer2023-11-08 14:08:40
Omeros Corp. ( OMER ) Tuesday said it received a decision from FDA on a formal dispute resolution request for Narsoplimab. The decision proposes the...
Business / FinanceBy Rtt News2023-11-08 14:08:40
(RTTNews) - Omeros Corp. (OMER) Tuesday said it received a decision from FDA on a formal dispute resolution request for Narsoplimab. The decision proposes...
MarketsBy Rtt News2023-10-21 11:19:10
(RTTNews) - Regeneron Pharmaceuticals, Inc. (REGN) announced the FDA has granted pediatric exclusivity for EYLEA Injection. This extends the period of U.S....
Business / FinanceBy Pr Newswire2024-09-14 11:15:00
SHENZHEN, China, Sept. 14,2022 /PRNewswire/ -- SMOORE Technology participated in a meeting with the United States Food and Drug Administration (FDA), as a...
Business / FinanceBy Rtt News2024-09-16 14:08:31
(RTTNews) - Heron Therapeutics Inc (HRTX), a commercial-stage biotechnology company, awaits FDA decision on its investigational drug HTX-019, proposed for...
Business / FinancePress Release2024-09-14 11:15:00
SHENZHEN, China, Sept. 14, 2022 /PRNewswire/ -- SMOORE Technology participated in a meeting with the United States Food and Drug Administration (FDA), as a...
MarketsBy Quentin Fottrell2024-09-23 16:53:00
The Food and Drug Administration spent months probing the nationwide shortage in baby formula, and conducted 40 interviews with more than 60 of its staff and...