(RTTNews) - Biopharmaceutical company Akebia Therapeutics, Inc. (AKBA) announced Thursday it has resubmitted its New Drug Application (NDA) to the U.S. Food...
(RTTNews) - Basilea Pharmaceutica Ltd announced the FDA has accepted for filing the New Drug Application for the antibiotic ceftobiprole. The FDA has set...
(RTTNews) - Liquidia Corporation (LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the company's amendment to the...
(RTTNews) - Phathom Pharmaceuticals, Inc. (PHAT), a biopharmaceutical company focused on gastrointestinal or GI diseases, announced Tuesday the submission of...
Nasdaq 2023-09-26 13:05:01 • 1 min
(RTTNews) - Takeda Pharmaceutical Co. Ltd. (TAK) announced Wednesday that the U.S. Food and Drug Administration has accepted for review its New Drug...
Nasdaq 2023-09-20 12:43:26 • 1 min
(RTTNews) - Biogen Inc. (BIIB) announced that the U.S. Food and Drug Administration has approved Tofidence (tocilizumab-bavi) intravenous formulation, a...
The Food and Drug Administration is now warning hospitals not to give probiotics to preterm infants, after a baby was killed by bacteria linked to a...
CBS News 2023-10-02 16:06:59 • 1 min
By Ernie Mundell HealthDay Reporter FRIDAY, Sept. 29, 2023 (HealthDay News) -- Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and...
U.S. News & World Report 2023-09-29 18:17:00 • 1 min
(RTTNews) - Apellis Pharmaceuticals, Inc. (APLS) announced the FDA has approved the EMPAVELI Injector. It is a single-use, on-body device designed to enhance...
Nasdaq 2023-10-02 11:27:06 • 1 min
By Cara Murez HealthDay Reporter THURSDAY, Sept. 28, 2023 (HealthDay News) An advisory panel to the U.S. Food and Drug Administration on Wednesday voted...
U.S. News & World Report 2023-09-28 10:44:00 • 1 min
(RTTNews) - Takeda (TAK) said that the U.S. Food and Drug Administration has approved a subcutaneous or SC administration of Entyvio (vedolizumab) for...
(RTTNews) - The U.S. Food and Drug Administration granted de novo marketing authorization for Invitae's Common Hereditary Cancers Panel, an in vitro...
(RTTNews) - IDEAYA Biosciences, Inc. (IDYA) said the FDA has granted Fast Track designation to development program investigating IDE161 for the treatment of...
Nasdaq 2023-09-27 10:29:47 • 1 min
(RTTNews) - Cabaletta Bio, Inc. (CABA), a clinical-stage biotechnology company focused on targeted cell therapies for patients with autoimmune diseases,...
Nasdaq 2023-10-02 12:15:06 • 1 min
The Food and Drug Administration on Tuesday declined to approve Neffy, an epinephrine nasal spray that offers a needle-free alternative for treating severe...
CBS News 2023-09-20 23:50:00 • 1 min
(RTTNews) - Hoth Therapeutics, Inc. (HOTH) announced the Pre-IND meeting previously requested for HT-KIT with the FDA has been granted to receive written...
Nasdaq 2023-10-02 12:51:04 • 1 min
(RTTNews) - Viatris Inc. (VTRS) and Ocuphire Pharma, Inc. (OCUP) announced the FDA has approved RYZUMVI 0.75% for the treatment of pharmacologically-induced...
Nasdaq 2023-09-27 12:20:00 • 1 min
Genetic testing that reveals potential cancer risks or other maladies with no regulatory oversight is among the targets of the agencys proposed review. The...
The New York Times 2023-09-29 18:55:05 • 1 min
WASHINGTON (AP) Federal health advisers voted overwhelmingly against an experimental treatment for Lou Gehrigs disease at a Wednesday meeting prompted by...
U.S. News & World Report 2023-09-27 22:15:30 • 1 min
In trading on Monday, shares of Idacorp Inc (Symbol: IDA) entered into oversold territory, changing hands as low as $90.28 per share. We define oversold...