FDA Newswire
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Published on May 17, 2024Source: BioWorld - Label Pending
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Published on 06:14 GMT
Latest News | Dr Reddy's, Sun Pharma, Aurobindo Recall Products in US
New Delhi, May 19 (PTI) Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma are recalling products in the US market due to manufacturing issues, as per the latest Enforcement Report of the US Food and Drug Administration (USFDA). Dr …
Source: Latestly - Uncategorized -
Published on 09:58 GMT
Dr Reddy’s, Sun Pharma and Aurobindo Pharma Recall Products in US Due to Manufacturing Issues
New Delhi, May 19: Drug makers Dr Reddy's Laboratories, Sun Pharma and Aurobindo Pharma are recalling their products in the US due to manufacturing issues. According to the latest Enforcement Report by the US Food and Drug Administration (USFDA), Dr …
Source: Latestly - Uncategorized -
Published on May 17, 2024
FDA Expedites Review of Petosemtamab in Head and Neck Cancer
The Food and Drug Administration (FDA) granted a breakthrough therapy designation for petosemtamab, a novel treatment for patients with recurrent or metastatic head and neck cancers, a news release stated. Specifically, the petosemtamab designation is for …
Source: Cure Today articles - Neutral -
Published on 08:12 GMT
Newspaper Headlines: North-east governors say zone neglected in capital projects allocation
Aliko Dangote’s assurance that Nigeria will end the importation of petrol by June dominated the cover pages of Nigerian newspapers. The Punch reports the presidency’s reaction to the planned alliance between Atiku Abubakar and Peter Obi, the 2023 …
Source: The Cable - Neutral -
Published on 09:04 GMT
NAFDAC Seals Off Cosmetic Shops in Lagos Impounds Fake Products
The National Agency for Food and Drug Administration and Control NAFDAC, has shut three shops and raided others during a clampdown on the sale of unregistered “Dr. Teal’s” brand of cosmetics in Lagos State. While disclosing this in a post on its X handle …
Source: The News Chronicle - Neutral -
Published on May 17, 2024
Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm
Cutting-edge tool analyzes data from cardiac remote monitoring devices to assess whether a patient is at high risk of experiencing worsening heart failure, enabling medical teams to intervene and avoid hospitalization. CAMBRIDGE, Mass., May 17, 2024 / …
Source: BioSpace - Neutral -
Published on May 17, 2024
Weekly review: FDA news, hypertension studies, and more
Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, May 13, to Friday, May 17, 2024), and click on each link to read and watch anything you may have missed. 1.) FDA approves ALTUVIIIO …
Source: Contemporary Pediatrics - Label Pending -
Published on May 17, 2024
BD wins FDA approval for cervical cancer screening self-collection kit
Dive Brief: BD said Wednesday it has received Food and Drug Administration approval for a kit for self-collection of specimens for human papillomavirus (HPV) testing. The approval allows people self-collect vaginal specimens in healthcare settings when …
Source: MedTech Dive - Washington D.C. - Label Pending -
Published on May 17, 2024
Amgen Wins FDA Approval for Difficult-to-Treat Lung Cancer
Pictured: Amgen's office in Tampa, Florida/iStock, JHVEPhoto The FDA on Thursday approved Amgen’s bispecific T-cell engager tarlatamab, which will now carry the brand name Imdelltra, for the treatment of extensive-stage small lung cancer in …
Source: BioSpace - Neutral -
Published on May 17, 2024
EU Regulator Pulls Approval for Preterm Labor Drug One Year After FDA
Pictured: Pregnant woman sitting in a chair in distress/iStock, Motortion The European Medicines Agency on Friday recommended withdrawing approval for a drug used to prolong gestation due to the lack of efficacy and a “possible but unconfirmed” risk of …
Source: BioSpace - Neutral -
Published on May 17, 2024
FDA of Women and Child Dept. in Lokayukta net
Mysore/Mysuru: A First Division Assistant (FDA), attached to the Department of Women and Child Development in Periyapatna taluk, was caught red-handed by Lokayukta personnel, while reportedly accepting bribe towards a favour at his office on Thursday. …
Source: Star of Mysore - Center-right -
Published on May 17, 2024
FDA rejects liver cancer drug combo, shares of Korean biotech tank
Korean biotech HLB and its China-based partner Jiangsu Hengrui Pharmaceuticals said Friday that the FDA rejected their drug combination for the most common form of liver cancer. The FDA rejected the pairing of rivoceranib and …
Source: Endpoints News - Neutral -
Published on May 17, 2024
FDA Approves New Drug for Deadly Lung Cancer
FRIDAY, MAY 17, 2024 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved a new drug to treat patients with an advanced form of deadly lung cancer. Importantly, tarlatamab (Imdelltra) is only for patients who have exhausted all …
Source: The Sunnyside Sun - Washington State - Neutral -
Published on May 17, 2024
FDA clears Nova’s Stat Profile Prime Plus analyzer for micro capillary sample mode
Nova Biomedical is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for a micro capillary sample mode on the Stat Profile Prime Plus® Critical Care analyzer. Prime Plus now performs an 11-test panel …
Source: Medical News - Neutral -
Published on May 17, 2024
Compatibility issues found with autoinjectors, FDA says
The FDA is warning healthcare professionals about compatibility issues between autoinjectors and glatiramer acetate injections, which are approved to treat relapsing forms of multiple sclerosis. If some autoinjectors are used with glatiramer acetate …
Source: Becker's Hospital Review - Neutral -
Published on May 17, 2024
FDA announces recall of Yogi tea brand due to pesticides
Oak Hill, WV (CNN)- Some tea drinkers must find something new to brew. Roughly 900 thousand tea bags from the organic ” Yogi ” brand have been recalled. The recall applies particularly to the Echinacea Immune Support tea. According to the Food and Drug …
Source: WOAY 4 - West Virginia - Neutral -
Published on May 16, 2024
FDA approves Amgen's treatment for most deadly form of lung cancer
The Amgen headquarters in Thousand Oaks, California. Eric Thayer | Bloomberg | Getty Images The Food and Drug Administration on Thursday approved Amgen's therapy for patients with the most deadly form of lung cancer. The agency cleared the drug, which …
Source: CNBC - Neutral -
Published on May 17, 2024
Adagio Medical wins FDA IDE for cryoablation study, completes first commercial cases in Europe
Adagio Medical announced today that it picked up FDA investigational device exemption (IDE) for a study of its VT cryoablation system. The Laguna Hills, California-based company also completed the first commercial procedures in Europe following CE mark …
Source: MassDevice - Neutral
Featured Releases
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Published on May 18, 2024 - 04:18 GMT
FDA Roundup: May 17, 2024
For Immediate Release: May 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for …
Distribution channels: Food & Beverage Industry -
Published on May 17, 2024 - 21:44 GMT
WITHDRAWN: FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma
UPDATE: On May 16, 2024, the FDA announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or …
Distribution channels: Healthcare & Pharmaceuticals Industry
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Published on May 16, 2024 - 11:00 GMT
Axogen Inc. Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration (FDA) for ...
ALACHUA, Fla. and TAMPA, Fla., May 16, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, is pleased to announce that it has initiated the rolling …
Distribution channels: Healthcare & Pharmaceuticals Industry ... -
Published on May 17, 2024 - 20:01 GMT
FDA Roundup: May 17, 2024
For Immediate Release: May 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for …
Distribution channels: Healthcare & Pharmaceuticals Industry
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Published on May 16, 2024 - 21:06 GMT
FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. Full …
Distribution channels: Healthcare & Pharmaceuticals Industry -
Published on May 15, 2024 - 21:02 GMT
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma
On May 15, 2024, the Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of …
Distribution channels: Healthcare & Pharmaceuticals Industry -
Published on May 15, 2024 - 21:02 GMT
Rationale for FDA's Position on Ceftazidime Breakpoints against Stenotrophomonas Maltophilia
FDA has reviewed data supporting ceftazidime breakpoints against Stenotrophomonas maltophilia. The review was conducted after the Clinical and Laboratory Standards Institute (CLSI) removed the breakpoints from the 34th edition of CLSI supplement M100 …
Distribution channels: Healthcare & Pharmaceuticals Industry -
Published on May 15, 2024 - 21:02 GMT
Types of FDA Inspections
The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products: Surveillance inspections Surveillance inspections are conducted to monitor the manufacturing process …
Distribution channels: Healthcare & Pharmaceuticals Industry
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Food & Beverage Industry Press Releases
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Published on May 19, 2024 - 14:59 GMT
Prokan Grills Unveils KANO, the First Outdoor Oven with Digital Temp Control, Delivering Precise Al Fresco Cooking
Company Introduces the KANO 4-in-1 Propane Outdoor Oven with Digital Temperature Control and Automatic Rotating Pizza Stone for Perfect Outdoor Meals TUSTIN, UNITED STATES, May 19, 2024 /EINPresswire.com/ -- Prokan Grills, a leader in high- …
Distribution channels: Consumer Goods, Culture, Society & Lifestyle ... -
Published on May 18, 2024 - 20:06 GMT
1764 Vineyards Announces The New Release of This Years, Sold Out 8 Years Later
They will offer first tastings to the public at the Wilcox Wine Festival this Weekend PHOENIX, ARIZONA, USA, May 18, 2024 /EINPresswire.com/ -- Media Contact: Elizabeth Lowney Creating Buzz PR elizabeth@creatingbuzzpr.com 415-948-5275 …
Distribution channels: Consumer Goods, Culture, Society & Lifestyle ... -
Published on May 18, 2024 - 16:14 GMT
Tekpon Reveals the Best Online Community Management Software
MIDDLETOWN, DELAWARE, UNITED STATES, May 18, 2024 /EINPresswire.com/ -- Tekpon, the online SaaS marketplace and software review platform, proudly announces its Best Online Community Management Software list. This selection highlights the top …
Distribution channels: Conferences & Trade Fairs, Culture, Society & Lifestyle ... -
Published on May 19, 2024 - 03:16 GMT
Mars Petcare US, Inc. Voluntarily Recalls 315 Bags of PEDIGREE® Adult Complete Nutrition Grilled Steak & Vegetable ...
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Distribution channels: -
Published on May 18, 2024 - 23:07 GMT
Mars Petcare US, Inc. Voluntarily Recalls 315 Bags of PEDIGREE® Adult Complete Nutrition Grilled Steak & Vegetable ...
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Distribution channels: -
Published on May 18, 2024 - 22:44 GMT
Mars Petcare US, Inc. Voluntarily Recalls 315 Bags of PEDIGREE® Adult Complete Nutrition Grilled Steak & Vegetable ...
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Distribution channels: -
Published on May 18, 2024 - 21:16 GMT
MenuSifu announces restaurant automation partnership with Happy Cashier and Hestia at NRA 2024
Chicago, May 18, 2024 (GLOBE NEWSWIRE) -- MenuSifu is celebrating its 10-year anniversary as a foodservice digital solutions provider by launching a series of new products and partnerships that will transform restaurant automation. Opening its largest …
Distribution channels: Conferences & Trade Fairs, Food & Beverage Industry ... -
Published on May 18, 2024 - 18:17 GMT
Update to Palmer Candy Company Recall of White Confectionary Products Because of Possible Health Risk
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Distribution channels: Food & Beverage Industry -
Published on May 18, 2024 - 17:59 GMT
Consumer Reports backs signing of high-risk AI bill, calls on Colorado General Assembly to strengthen it before it goes ...
Consumer Reports commends Colorado Gov. Jared Polis for signing SB 205, a bill that would establish baseline accountability and transparency for the use of AI in high-stakes decisions affecting consumers and workers, such as decisions about access to …
Distribution channels: -
Published on May 18, 2024 - 17:43 GMT
Update to Palmer Candy Company Recall of White Confectionary Products Because of Possible Health Risk
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Distribution channels: Food & Beverage Industry -
Published on May 18, 2024 - 17:40 GMT
Update to Palmer Candy Company Recall of White Confectionary Products Because of Possible Health Risk
COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …
Distribution channels: Food & Beverage Industry -
Published on May 17, 2024 - 20:48 GMT
Day of Rock 2 Festival: Asheville's Premier All-Rock Music Event is Set to Rock the Grey Eagle on August 17 and 18
Day of Rock 2 Festival Featuring 28 rock bands over 2 consecutive days is coming to the Grey Eagle in August. ASHEVILLE, NC, USA, May 17, 2024 /EINPresswire.com/ -- Day of Rock, LLC, is bringing a 2 day all rock music festival to Asheville, the …
Distribution channels: Culture, Society & Lifestyle, Food & Beverage Industry ... -
Published on May 17, 2024 - 20:30 GMT
St Louis Native Dan Liddell Joins Hooligans Music Group as Producer and CEO of St Lou Hitz
ST LOUIS, MISSOURI, UNITED STATES, May 17, 2024 /EINPresswire.com/ -- St. Louis native Dan Liddell, known for his impressive production credits with artists such as 2Chainz, Young Dolph, Kanye West, Young Dro, Memphis Moe and Young Thug, has …
Distribution channels: Book Publishing Industry, Culture, Society & Lifestyle ... -
Published on May 17, 2024 - 20:06 GMT
Ben’s Soft Pretzels Sets Sail With Shipwreck Island: A New Pretzel “Container” Bakery in Panama City Beach, Florida
Ben’s Soft Pretzels Sets Sail With Shipwreck Island: A New Pretzel “Container” Bakery in Panama City Beach, Florida. PANAMA CITY BEACH, FL, USA, May 17, 2024 /EINPresswire.com/ -- Ben’s Soft Pretzels, the beloved purveyor of warm, doughy …
Distribution channels: Amusement, Gaming & Casino, Business & Economy ... -
Published on May 17, 2024 - 20:04 GMT
Tekpon Announces the Best Restaurant Management Software for Hospitality Industry
MIDDLETOWN, DELAWARE, UNITED STATES, May 17, 2024 /EINPresswire.com/ -- Tekpon, the online SaaS marketplace and software review platform, proudly announces its Best Restaurant Management Software list. This carefully curated selection showcases …
Distribution channels: Companies, Consumer Goods ... -
Published on May 17, 2024 - 20:02 GMT
Dorian Drake International Receives Prestigious "E" Award in Recognition of Outstanding Export Promotion Efforts
Dorian Drake awarded the prestigious President's "E” Award, authorized by the U.S. Secretary of Commerce, for its contributions to U.S. export expansion. WHITE PLAINS, NEW YORK, UNITED STATES, May 17, 2024 /EINPresswire.com/ -- Dorian …
Distribution channels: Automotive Industry, Chemical Industry ... -
Published on May 17, 2024 - 19:43 GMT
Cheers to Seven Years: Angry Horse Brewing Celebrates Community and Collaboration
Montebello’s favorite brewery gears up to celebrate their 7th anniversary. MONTEBELLO, CA, USA, May 17, 2024 /EINPresswire.com/ -- Montebello’s favorite brewery is gearing up for a grand celebration! Angry Horse Brewing, the award-winning craft …
Distribution channels: Business & Economy, Companies ... -
Published on May 17, 2024 - 18:58 GMT
Recruiting for Good Launches The Sweetest Dining Gift Card to Help Fund Causes
Staffing agency Recruiting for Good helps companies find professionals, generates proceeds to fund causes; and is rewarding referrals with two $1500 Gift Cards. SANTA MONICA, CALIFORNIA, UNITED STATES, May 17, 2024 /EINPresswire.com/ -- …
Distribution channels: Business & Economy, Culture, Society & Lifestyle ... -
Published on May 17, 2024 - 18:14 GMT
SIP Awards Reveals the 2024 International Spirits & Mixers Competition Winners
IRVINE, CA, USA, May 17, 2024 /EINPresswire.com/ -- The SIP Awards, the esteemed consumer judging spirits competition, is excited to reveal the winners of the 2024 competition. This year’s event showcased an impressive array of spirits and mixers …
Distribution channels: Companies, Conferences & Trade Fairs ... -
Published on May 17, 2024 - 18:12 GMT
One of Arizona’s Newest Wineries Took a Chance To Follow Their Passion And Their Awards Show it Is Paying Off
1764 Vineyards Just Won Double Gold in San Francisco and Best Arizona Red Wine Here PHOENIX, ARIZONA, USA, May 17, 2024 /EINPresswire.com/ -- FOR IMMEDIATE RELEASE Media Contact: Elizabeth Lowney Creating Buzz PR elizabeth@creatingbuzzpr. …
Distribution channels: Consumer Goods, Culture, Society & Lifestyle ...
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