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FDA Has Recalled Thousands of Bottles of Antidepressant Duloxetine, Sold Under Brand Name Cymbalta: Here’s Why
23 Oct 2024 05:33 GMT
People
… consequences," according to the FDA. The Towa Pharmaceutical Europe- … be present in drugs. FDA found the source of nitrosamines … can also be formed. FDA continues to test and research … taking their medications," the FDA added. "Patients should …
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FDA cautions public against of sale of galamsey water
23 Oct 2024 05:04 GMT
Modern Ghana
The Food and Drugs Authority (FDA) has called on the … as “Galamsey Water.” The FDA stressed that packaging unwholesome water … . The statement said the FDA was actively collaborating with security … activities. It said the FDA would not tolerate practices that …
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7,100 bottles of antidepressant recalled by FDA now in 2nd highest risk class
23 Oct 2024 06:09 GMT
Michigan Local News
… Administration. Earlier this month the FDA announced a recall of 7 … nitroso-duloxetine. On Thursday, the FDA elevated the recall to a … is remote.” According to the FDA, Duloxetine -- which is marketed … has been recalled, the FDA says those who have been …
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FDA clears Gentuity imaging system for coronary interventions
23 Oct 2024 01:29 GMT
MassDevice
… announced today that it received FDA 510(k) clearance for its … are excited to receive this FDA clearance, which marks a major …
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STAT+: Novo asks FDA to bar compounders from making Ozempic copies
23 Oct 2024 01:21 GMT
STAT - Massachusetts
… be in shortage by the FDA, which semaglutide has been for … obesity, should be on the FDA’s “Demonstrable Difficulties for Compounding … agency posted this week. The FDA still has to make a …
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FDA funding fuels research on turkey parasite and potential treatments
23 Oct 2024 01:07 GMT
Medical News
… and potentially finding an existing FDA-approved drug to fight … Innovation Center. According to the FDA, these centers aim to … in poultry. However, the FDA banned their use in animals … supporting evidence leading to the FDA grant. The researchers showed …
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FDA regularises services of employees
23 Oct 2024 00:50 GMT
The Nation
… - The Faisalabad Development Authority (FDA) regularized services of its employees … on Tuesday. Director General (DG) FDA Muhammad Asif Chaudhry has issued …
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FDA approval for Cobenfy casts light on schizophrenia’s wickedness
23 Oct 2024 00:10 GMT
The Hindu
… .S. Food and Drug Administration (FDA) approved a drug called Cobenfy … that has just received the FDA’s approval, “is the first … the standard of care,” the FDA said in a statement. According … as an antimuscarinic agent”. The FDA said Cobenfy’s most common …
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FDA Approves Companion Diagnostic for Zolbetuximab in CLDN18.2+ Gastric/GEJ Cancer
22 Oct 2024 23:57 GMT
OncLive
… deterioration. References Roche receives FDA approval for the first companion … gastric or gastroesophageal junction adenocarcinoma. FDA. October 18, 2024. Accessed … resources-information-approved-drugs/fda-approves-zolbetuximab-clzb-chemotherapy-gastric …
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FDA issues CRL: Inspection woes hold up Camurus’ acromegaly drug
22 Oct 2024 23:46 GMT
BioWorld
… (CRL) from the U.S. FDA for CAM-2029 (octreotide), its … . Camurus will work with the FDA and the third-party manufacturer … ;metabolic Small molecule U.S. FDA
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FDA Approves Vyalev for Advanced Parkinson Disease
22 Oct 2024 23:40 GMT
HealthDay
TUESDAY, Oct. 22, 2024 (HealthDay News) -- The U.S. Food and Drug Administration has approved Vyalev (foscarbidopa and foslevodopa) for adults living with advanced Parkinson disease (PD). Vyalev is the first and only subcutaneous 24-hour continuous …
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Gradient adds former Edwards exec to board as FDA approves trial expansion
22 Oct 2024 23:10 GMT
MassDevice
… -based Gradient also said the FDA approved an expansion of its … ) with associated heart failure. The FDA gave the green light to …
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Siemens Healthineers wins FDA nod for heart-attack-predicting test
22 Oct 2024 23:10 GMT
MassDevice
Siemens Healthineers says a new FDA clearance will advance the care … the United States to receive FDA clearance for such a one …
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FDA names Tarver as new head of device center
22 Oct 2024 23:10 GMT
BioPharma Dive
… leader Jeff Shuren stepped down. FDA Commissioner Robert Califf emphasized Tarver … someone who has served the FDA for more than 15 years …
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Peytant wins FDA de novo nod for covered stent system
22 Oct 2024 23:10 GMT
MassDevice
… Solutions announced today that the FDA granted marketing authorization for its …
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FDA expands approval of Stelara biosimilar Selarsdi to include UC, Crohn’s disease
22 Oct 2024 21:49 GMT
Healio News
… .S. in early 2025. The FDA approved the Stelara biosimilar, Selarsdi … market in early 2025. The FDA approved the Stelara biosimilar, Selarsdi …
- US FDA approves Pfizer’s RSV vaccine for adults at increased risk of the disease 22 Oct 2024 22:00 GMT KFGO - North Dakota
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FDA: Be ready to comply on food traceability
22 Oct 2024 21:12 GMT
The Fence Post - Nebraska
… consumer safety officer in the FDA’s Human Foods Program, said …
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STAT+: Michelle Tarver to lead FDA medical device center
22 Oct 2024 20:58 GMT
STAT - Massachusetts
… STAT and sent out to FDA device staff on Tuesday afternoon … times in my years at FDA,” said FDA Commissioner Robert Califf in …
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U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease
22 Oct 2024 20:47 GMT
Business Wire
… S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial … and pregnant women.” The FDA’s decision is based on … . In May 2023, the FDA approved ABRYSVO for the prevention … . In August 2023, the FDA approved ABRYSVO for the prevention …
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Savara sponsors Lifetime talk show episode about rare respiratory disease ahead of FDA submission
22 Oct 2024 20:42 GMT
Fierce Pharma
… its molgramostim inhalation solution for FDA approval to treat autoimmune pulmonary … planning to wrap up its FDA biologics license application for molgramostim …
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FDA Clears IND of ADRX-0405, Next-Gen ADC, in Solid Tumors
22 Oct 2024 20:29 GMT
Targeted Oncology
The FDA has cleared the investigational new … been cleared by the FDA.1 “The FDA’s clearance of our … REFERENCES: 1. Adcentrx Therapeutics announces FDA clearance of investigational new drug …
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FDA Approves Selarsdi as Biosimlar to Stelara in an Intravenous Formulation
22 Oct 2024 20:01 GMT
Pharmacy Times
… com/view/fda-approves-ustekinumab-biosimilar-to-stelara … psoriasis 3. Gallagher A. FDA Approves Ustekinumab-ttwe as Biosimilar … com/view/fda-approves-ustekinumab-ttwe-as- … com/view/fda-approves-imuldosa-ustekinumab-biosimilar-for …
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FDA Seizes 3 Million Unauthorized E-Cigarettes in Joint Federal Operation
22 Oct 2024 19:44 GMT
Convenience Store News & Petroleum
… our nation’s borders,” said FDA Commissioner Robert M. Califf. “ … unscrupulous activity.” In June, the FDA and the Department of Justice … unsafe and unlawful goods.” The FDA said the joint team worked … with the law.” The FDA said the joint federal task …
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FDA Approval of Trodelvy Withdrawn for Urothelial Carcinoma
22 Oct 2024 19:18 GMT
Cure Today
… the Food and Drug Administration (FDA) accelerated approval of Trodelvy ( … made in discussion with the FDA. Gilead Sciences noted that … accelerated approval from the FDA in April 2021 for … duration of response. The FDA noted that the continued approval …