FDA News Monitoring

FDA gives misleading information

In September, the Food and Drug Administration launched a new initiative designed to tackle the “growing spread of rumors, misinformation and disinformation about science, medicine and the FDA.”  Announcing the initiative, FDA Commissioner Robert Califf …

FDA approves Rezlidhia™ for leukaemia

Rezlidhia™ has been approved for adults with mIDH1 relapsed/refractory acute myeloid leukaemia by the US Food and Drug Administration (FDA). Rigel Pharmaceuticals, Inc. has announced the US Food and Drug Administration (FDA) has approved its oral drug …

FDA pulls last COVID-19 monoclonal antibody treatment as new variants rise

Monoclonal antibody drugs to treat COVID-19 infections are no longer available in Minnesota, health officials have confirmed.  The U.S. Food and Drug Administration on Wednesday announced it had ended emergency use authorization for Eli Lilly's …

FDA Clears First IND for a Multiplex-Base Edited Investigational Therapy

Al Drago/CQ Roll Call/Getty Images The FDA has lifted its clinical hold on Beam Therapeutics’ BEAM-201 and cleared the way for an Investigational New Drug Application, the company announced Friday. BEAM-201 is an anti-CD7, multiplex-edited, …

FDA grants clearance for neurological monitoring device

December 02, 2022 1 min read Medical device company WISE Srl announced the FDA granted clearance for its Cortical Strip, a single-use device intended to be used on the brain surface for intraoperative neurophysiological monitoring. According to the company …

FDA issues ‘study may proceed’ letter for clinical trial for MDD treatment

December 02, 2022 1 min read ADD TOPIC TO EMAIL ALERTS Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio The FDA has issued a “study may …

AGA ‘applauds FDA’ for first approved fecal microbiota biotherapeutic

December 02, 2022 1 min read ADD TOPIC TO EMAIL ALERTS Subscribe We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Following FDA approval of the …

FDA grants fast track, RMAT designations to CAR-T for advanced non-Hodgkin lymphoma

December 02, 2022 1 min read The FDA granted fast track and regenerative medicine advanced therapy designations to CB-010, a chimeric antigen receptor T-cell therapy, for the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma. The fast track …

FDA Announces Monoclonal Antibody Not Authorized Due to Inability to Fight Omicron

A year after the omicron variant of COVID-19 began to upend the world and start a new stage of the pandemic, several new subvariants have originated from the variant, with reaction to treatment changing along with the subvariants. With the recent rise of …

FDA approved a 1st-of-its-kind treatment made from human poop. What does it do?

For the first time, the Food and Drug Administration (FDA) has approved a treatment that's made using donated human poop, the agency announced (opens in new tab) Wednesday (Nov. 30). The treatment, called Rebyota, contains gut bacteria collected from …

FDA May Update Its Policy on Blood Donations From Gay and Bi Men

More gay and bisexual men may be able to donate blood and plasma in 2023, reports CNN, noting that the Food and Drug Administration (FDA) has signaled that it may ease its policy on blood donations from men who have sex with men. This population had once …

FDA Greenlights Rigel's Rezlidhia in IDH1-Mutation AML

Sarah Silbiger/Getty Images The FDA has approved Rigel Pharmaceuticals' Rezlidhia (olutasidenib) for the treatment of adults with relapsed or refractory (r/r) acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) …

Doctors optimistic about first treatment approved by the FDA to delay the onset of Type 1 diabetes

Doctors say it's the biggest breakthrough in Type 1 diabetes since insulin itself was discovered. GREENSBORO, N.C. — The FDA recently approved the first treatment to delay the onset of Type 1 diabetes. Dr. Mark Guido is an endocrinologist with Novant …

FDA Expands List of Getinge IABP System and Component Shortages

The US Food and Drug Administration (FDA) today issued a letter to healthcare providers describing a current shortage of Getinge intra-aortic balloon pump (IABP) catheters and other components. Earlier this week, the agency announced shortages of the …

Health Headlines: FDA pulls COVID antibody treatment

by: Darren Kramer Posted: Dec 2, 2022 / 01:10 PM EST Updated: Dec 2, 2022 / 01:11 PM EST Conn. (WTNH) — In today’s health headlines, the FDA pulled a COVID antibody treatment. Could lung COVID become the next public health disaster? Additionally, …

Comment from AGA: FDA actions on fecal microbiota therapy

On Nov. 30, FDA approved the first fecal microbiota therapy for recurrent Clostridioides difficile infection (CDI). This approval came days after FDA issued guidance on regulatory requirements for stool banks providing fecal microbiota transplantation (FMT …

Former FDA regulatory section chief joins RegenMed Development Organization

Former FDA Regulatory Section Chief Joins ReMDO

Newswise — WINSTON-SALEM, NC, DECEMBER 2, 2022 – A former FDA official with  31 years of regulatory experience, clinical trials oversight and research experience in cell-based biological therapies is joining the Regenerative Medicine Hub (RegenMed Hub) …

FDA Declines to Approve Y-mAbs's Pediatric Cancer Drug

(Reuters) - The U.S. health regulator on Thursday declined to approve a treatment from Y-mAbs Therapeutics for a rare form of nerve cancer in pediatric patients, dragging the company's shares down 16% in extended trading. Y-mAbs said it is assessing …

Project Boon Announces Holiday Giveaway Event at the Bloomington Community Health Center

The event, scheduled for December 20th, will include groceries, toys, and a visit from Santa himself. ONTARIO, CALIFORNIA, UNITED STATES, December 2, 2022 /⁨EINPresswire.com⁩/ -- Since its inception in 2011, Project Boon has been a force of good …

Equator Releases Ultra Spacious Beverage Refrigerator for the Holiday Season

Compact yet built to hold 108 cans and six wine bottles at one time, this upscale cooling solution is the perfect high-end gift HOUSTON, TEXAS, UNITED STATES OF AMERICA, December 2, 2022 /⁨EINPresswire.com⁩/ -- With multiple premium features in …

Vanilla Bean Market is expected to be worth US$ 4 Bn by the year 2031

Global Market Study on Vanilla Beans: High Demand for Vanilla Flavored Products Across Industries Surging Demand NEW YORK, NY, UNITED STATES, December 2, 2022 /⁨EINPresswire.com⁩/ -- Vanilla Bean Market: Vanilla and vanillin are the most …

The United States welcomes once again the "MADE IN PORTUGAL naturally" campaign

A national B2B digital campaign that brings all American companies closer to the very best of Portuguese Brands, Products and Services. NEW YORK CITY, NEW YORK, USA, December 2, 2022 /⁨EINPresswire.com⁩/ -- The "MADE IN PORTUGAL naturally…

Numly, Inc. Unveils its Winter 2022 Release of NumlyEngage with "Connected Leadership" Skills Framework

Numly, Inc. Unveils its Winter 2022 Release of NumlyEngage - A SaaS Coaching Platform to help Organizations develop “Connected Leaders” at all levels BELLEVUE, WASHINGTON, USA, December 2, 2022 /⁨EINPresswire.com⁩/ -- Numly™, Inc. today unveiled …

Blue Ridge Hospitality Group Opens Eagle Bar & Grill - A Hidden Gem In WNC

The finest, freshest ingredients combined with years of culinary expertise produce beautifully handcrafted cuisine. HENDERSONVILLE, NORTH CAROLINA, UNITED STATES, December 2, 2022 /⁨EINPresswire.com⁩/ -- In 2020, despite Covid-19, the Founder of …

Vacuum Interrupters Market Size to Boost USD$3.2 billion By 2027 | CAGR 5.3% - IndustryARC

Based on the application in the Vacuum Interrupters Market, the Circuit Breaker is expected to grow at the highest rate during the forecast period. HYDERABAD, TELANGANA, INDIA, December 2, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest …

Readymade Garment Market Revenue, Major Players, Consumer Trends, Analysis & Forecast Till 2027 – IndustryARC

Readymade Garment Market growth is being driven by the surging trend of fashion and its impact on buyers. HYDERABAD, TELANGANA, INDIA, December 2, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest report, predicts that Readymade Garment …

Natural Sweeteners Market Size Expected to Reach USD $3.9 billion with CAGR of 6.3% by 2027 – IndustryARC

The Natural Sweeteners Market is predicted to increase owing to its growing demand in bakeries and food and beverages. HYDERABAD, TELANGANA, INDIA, December 2, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest report, predicts that Natural …

Vitamins Market to Reach US$8.3 billion by 2027: IndustryARC

Surging Applications of Vitamins for Bones, Connective Tissues, Muscles and Blood Vessels are Projected to Drive the Growth of the Vitamins Market HYDERABAD, TELANGANA, INDIA, December 2, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in its latest …

Fruit Fiber Market worth $356.7 million by 2027 at a growth rate of 4.2% - IndustryARC

Jaw-dropping expansion in inflation rates, plummeting yield of fruit because of environmental calamities, and unemployment are said to reduce the market growth. HYDERABAD, TELANGANA, INDIA, December 2, 2022 /⁨EINPresswire.com⁩/ -- IndustryARC, in …

Global Instant Pudding Market Key Players, Growth, Share, Demand & Supply 2033

Global Instant Pudding market financial planning, business expansion plans 2022-2033 Dr.Oetker, Kroger, Goodman Fielder, KRAFT HEINZ NEW YORK CITY, NY, UNITED STATES, December 2, 2022 /⁨EINPresswire.com⁩/ -- The global Instant Pudding Market is …

Mintec acquires CommoPrices to extend its coverage of commodity price data and intelligence

LONDON, UNITED KINGDOM, December 2, 2022 /⁨EINPresswire.com⁩/ -- Mintec acquires CommoPrices to extend its coverage of commodity price data and intelligence. • Expanding customers ‘one-stop shop’ access to commodity price data, analysis, and …

The sustainability report of Löfbergs: “We cannot climate-compensate away the challenges in the coffee industry.”

KARLSTAD, VARMLAND, SWEDEN, December 2, 2022 /⁨EINPresswire.com⁩/ -- Through purposeful efforts and large investments, Swedish-based Löfbergs has successfully reduced its climate impact with 90 per cent over the last three years. The results are …

New drugs to strike obesity fast tracked

The FDA has granted new drugs a Fast Track designation to treat obesity, as it has shown comparable potential to gastric bypass surgery. TENAFLY, NEW JERSEY, UNITED STATES, December 2, 2022 /⁨EINPresswire.com⁩/ -- In October, the US FDA granted …

The Global Meat Substitutes Market Value is Predicted to Hit USD 3.5 billion by 2027

HYDERABAD, TELANGANA, INDIA, December 2, 2022 /⁨EINPresswire.com⁩/ -- Product Description: The global meat substitutes market size was valued at USD 1.6 billion in 2021, and it is estimated to reach USD 3.5 billion by 2027, with a registering …

Couscous Market Potential Growth And Worldwide Driving Factors

The Global Couscous Market Research Report 2022 offers comprehensive market information, including recent trends and developments NEW YORK, NY, UNITED STATES, December 1, 2022 /⁨EINPresswire.com⁩/ -- Market.biz's Global Couscous Market Study …

Gelato Market Is Thriving Globally By 2032 - Competition Analysis

The Global Gelato Market Research Report 2022 offers comprehensive market information, including recent trends and developments NEW YORK, NY, UNITED STATES, December 1, 2022 /⁨EINPresswire.com⁩/ -- Market.biz's Global Gelato Market Study has …

Citrus Yogurt Market Analysis, Trends, Growth, Challenges, and Key Players by 2030

Combine the sugar and lemon juice in a large bowl until they are well combined. Mix the yogurt with the lemon zest until smooth. Serve it with fresh fruits. NEW YORK, NY, UNITED STATES, December 1, 2022 /⁨EINPresswire.com⁩/ -- Combine the sugar …

Cochineal Extract Market Latest Viewpoints

The Global Cochineal Extract Market Research Report 2022 offers comprehensive market information, including recent trends and developments NEW YORK, NY, UNITED STATES, December 1, 2022 /⁨EINPresswire.com⁩/ -- Market.biz's Global Cochineal …