FDA News Monitoring

OncLive’s December Roundup of Key FDA Approvals in Oncology

Below is your guide to all treatment options that the FDA cleared in December 2024. The recap spotlights the topline data that supported the regulatory decisions and features expert insights on what they mean for clinical practice. 12/4: Durvalumab in …

July - September 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event ...

The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this …

Killing corruption

A lawmaker wants the death penalty back — by firing squad, rather than by lethal injection. House Bill No. 11211, filed by Zamboanga City Rep. Khymer Adan T. Olaso, proposes the death penalty for all public officials — from the President down to barangay …

Nearly Forgotten ‘Phage Therapy’ Fights Antibiotic Resistance

Imagine that the next time you catch a stomach bug and antibiotics fail to work, you knock back a vial of clear liquid. The solution teems with bacteriophages, viruses resembling tiny rocket ships. These benign microbes exclusively dock onto and destroy …

FDA approves BMS’ Opdivo Qvantig for solid tumour indications

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo Qvantig for subcutaneous use to treat various solid tumours. This new combination product, which includes nivolumab co-formulated with recombinant human …

US FDA approves BeiGene's Tevimbra in combination with chemotherapy for first─line treatment of gastric and ...

BeiGene, Ltd., a global oncology company that intends to change its name to BeOne Medicines Ltd., announced the US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based …

FDA recalls hair spray brand in 12 states over solvent linked to health risks

(TNND) — The FDA has announced a recall of a hair spray brand in 12 states after it was discovered that the product contains dichloromethane — a solvent that is commonly used in industrial applications and is a potential health risk. Newsweek reports the …

Sequana gets FDA nod for Alfapump to treat patients with ascites

Precigen Soars: Biologics License Application Submission For PRGN-2012 Targets First FDA-Approved Recurrent Respiratory ...

Precigen, Inc. PGEN shares are trading higher on Monday after the company completed the rolling submission for a biologics license application to the FDA for PRGN-2012 (zopapogene imadenovec) to treat adult patients with recurrent respiratory …

FDA approves BeiGene’s TEVIMBRA combo for treating certain gastric cancers

The US Food and Drug Administration (FDA) has granted approval for BeiGene’s TEVIMBRA (tislelizumab-jsgr) for the treatment of adults with specific types of gastric cancer. The new indication specifically targets unresectable or metastatic human epidermal …

Sepsis ImmunoScore: The First FDA-Authorized AI Tool for Early Sepsis Detection and Risk Assessment

Sepsis is a critical medical condition resulting from an abnormal immune response to infection, often causing organ dysfunction and high morbidity and mortality rates. Prompt treatment, especially with antibiotics, can significantly improve outcomes. …

Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 ...

DURHAM, N.C., Dec. 30, 2024 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ: CMRX), a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases, today confirms that the Company …

FDA weighs red No. 3 ban

The Food and Drug Administration is on the cusp of deciding whether to ban a controversial bright cherry-red dye used in drinks and snacks but that has been linked to cancer in animals. Food safety advocates for years have pressured the agency to ban the …

Discussing FDA approved neffy with Russell Libby, MD, FAAP

A new needle-free epinephrine delivery method may transform the management of anaphylaxis in pediatric patients. Russell Libby, MD, FAAP, founder and president of Virginia Pediatric Group, expressed enthusiasm about epinephrine nasal spray (neffy; ARS …

My Turn: Abortion pills are here to stay

In November 2022, a group of anti-abortion doctors and a dentist filed a lawsuit in Amarillo, Texas, challenging the U.S. Food and Drug Administration’s approval of the abortion pill mifepristone in 2000. They asked the court to ban the medication …

Could the FDA's Approach to Vaping Cause an Increase in Smoking?

In early December, the Supreme Court heard oral argument in Food and Drug Administration v. Wages and White Lion Investments, a challenge to the FDA's denial of marketing approval for flavored vaping products. The specific question before the Court is …

FDA D.I.S.C.O. Burst Edition: FDA approval of Bizengri (zenocutuzumab-zbco) for Treatment of adults with advanced ...

Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update …

COVID-19 at-home tests and expiration dates

By Deb Balzer Respiratory illnesses, like COVID-19, flu, strep throat and RSV, are common in the fall and winter. Because COVID-19, influenza and RSV symptoms can overlap, it’s not always easy to tell them apart. Taking a home antigen test for COVID-19 is …

Microbot Medical® Concludes 2024 by Achieving Key Milestones Culminating in FDA Submission for the Commercialization of ...

BRAINTREE, Mass., Dec. 30, 2024 (GLOBE NEWSWIRE) -- Microbot Medical Inc. (Nasdaq: MBOT), developer of the innovative LIBERTY® Endovascular Robotic System, concludes 2024 with the achievement of several key milestones, including the recent FDA 510(k) …

Celebrity Bartending Company This Girl Walks Into a Bar Launches Premium Organic Cocktail Mixer Line

California Sisters and Co-Founders Jordan Catapano and Jocelyn Dunn Build on Bartending Company Success to Launch Mixer Line LOS ANGELES, CA, UNITED STATES, January 2, 2025 /⁨EINPresswire.com⁩/ -- Jordan Catapano and Jocelyn Dunn, sisters and …

Food Acidulants Market to Reach USD 4.5 Billion by 2033 with Rising Demand for Processed and Flavored Foods

The bakery and confectionery segment leads the food acidulants market, driven by rising demand for packaged foods and extended shelf life benefits. NEWARK, DE, UNITED STATES, January 2, 2025 /⁨EINPresswire.com⁩/ -- The food acidulants market …

Broccoli Cannabis Weed Dispensary Los Angeles Expands Local Cannabis Product Line

Broccoli Cannabis introduces diverse strains and products, enhancing offerings to meet the evolving needs of Los Angeles cannabis enthusiasts. LOS ANGELES, CA, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- Broccoli Cannabis Weed …

Dried Scallop Market Opportunities, Key Players and Forecast 2021-2031 | WHOLEY'S, Gyoren Hokko, HK JEBN

WILMINGTON, DE, UNITED STATES, January 2, 2025 /⁨EINPresswire.com⁩/ -- Global Dried Scallop Market Size was valued at $264.50 million in 2021, and is estimated to reach $374.6 million by 2031, growing at a CAGR of 3.6% from 2022 to 2031. …

Tonic Water Market Size, Share And Growth Analysis For 2021-2027 | Q MIXERS, FEVER-TREE, DR. PEPPER SNAPPLE

WILMINGTON, DE, UNITED STATES, January 2, 2025 /⁨EINPresswire.com⁩/ -- Global Tonic Water Market Size was valued at $805.4 million in 2019, and is projected to reach $1,168.9 million by 2027, registering a CAGR of 7.3% from 2021 to 2027. The market …

Going Dry? Doesn't Matter Why. Heineken® 0.0's New Campaign Says Alcohol-Free Should Be Reason-Free

AMSTERDAM, Jan. 02, 2025 (GLOBE NEWSWIRE) --  People's drinking habits are changing, so do we still need abstinence months like 'Dry January' and 'Sober October' in the diary to choose non-alcoholic options? New research from Heineken® …

Osechi Cuisine Prices Polarize in Japan: High-End vs. Budget-Friendly Options Emerge

Japan is facing the impact of high prices. The price of Osechi cuisine has had a chain reaction, and the polarization between “luxury” and “affordable” has progressed. TOKYO, JAPAN (MERXWIRE) – As the world welcomes the New Year, the Japanese people’s …

Half Price Packaging Sets New Sustainability Goals for New Year 2025

As the New Year begins, Half Price Packaging renews its pledge to sustainability with improved goals for a greener 2025. FREMONT, CA, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- With 2024 coming to an end, Half Price Packaging is …

New Online Grocery Website Launches, Making Shopping Easier and More Convenient

NEW DELHI, DELHI, INDIA, January 1, 2025 /⁨EINPresswire.com⁩/ -- Aap Ka Bazar, the leading online grocery store, is proud to announce the launch of its new website and mobile apps, making grocery shopping easier and more convenient than ever before …

Tyler Florence, Ana Sofia & PopUp Bagels Headline Inaugural 5850 Fest’s “Summit to Table” Culinary Program

Idaho’s Premier Entertainment, Culinary & Cultural Festival Boasts VIP Dining Experiences, Interactive Demos & Gourmet Pop-ups in Heart of Sawtooth Mountains KETCHUM, ID, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- 5850 Fest, …

The Paper Packaging Company Announces Expansion to the United States

HOUSTON, TX, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- The Paper Packaging Company, founded by Nigerian engineer and entrepreneur Chidi Oguegbu, will extend its eco-conscious operations to the United States in early March. The …

Specialty Carbohydrates Market to Hit USD 10.8 Billion by 2033 Driven by Nutritional Trends & Health-Conscious Consumers

Rising health awareness and nutraceutical spending drive global demand for specialty carbohydrates, particularly in emerging markets. NEWARK, DE, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- The global specialty carbohydrates market is …

Adfuel Accelerates Success in the Food and Beverage Franchise Industry

Adfuel, is proud to announce its latest partnership with The Franchise Edge, a Tampa-based consultancy specializing in food and beverage franchises. TAMPA, FL, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- Adfuel, an industry leader in …

MSL COPACK + ECOMM Gears Up to Empower Clients for a Successful 2025 After a Thriving Holiday Season

INDIANAPOLIS, IN, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- As the curtain falls on the 2024 holiday season, MSL COPACK + ECOMM is already looking ahead to 2025 with renewed energy and commitment to helping clients achieve their goals. …

Anhydrous Milk Fat Market Size is Projected to Attain $6 Billion By 2031: Lactalis, Interfood Holding BV, Vitusa Corp

The anhydrous milk fat market size was valued at $3 billion in 2021, and is estimated to reach $6 billion by 2031, growing at a CAGR of 7.2% from 2022 to 2031 WILMINGTON, DE, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- Technology …

Juiced Up for Victory: Pickle Juice® Partners with Turbo Velo Cycling Team

The functional beverage brand is ensuring that Turbo Velo remains cramp-free for the 2025 Season MESQUITE, TX, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- Pickle Juice®, the only product scientifically proven to stop muscle cramps, is …

Portable Food Safety Detectors Market Size Expected to Reach $11.8 Billion by 2031

Portable food safety detectors market size was valued at $6.9 billion in 2021, and is estimated to reach $11.8 billion by 2031, growing at a CAGR of 5.5% WILMINGTON, DE, UNITED STATES, January 1, 2025 /⁨EINPresswire.com⁩/ -- Portable food safety …

Mass. Bay Brewing Company and Finestkind Brewing Unite to Form Barrel One Collective

Two Originals of New England Brewing Merge to Form Region’s Leading Craft Beer Producer BOSTON, MA, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- In a landmark merger between two pioneers of New England’s craft beer industry, Mass. Bay …

Crumbl Celebrates Sweet Milestones to Ring in 2025

LINDON, UT, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- As 2024 draws to a close, Crumbl is as dedicated as ever to bring friends and family together over the best desserts in the world. Creating the highest quality experience possible …

Workweek Lunch Meal Planner Launches Instacart Integration to Simplify Meal Prep

Helping People Build Long Lasting Cooking Habits Without the Stress of Tracking Calories CHARLOTTE, NC, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- Workweek Lunch, the meal-planning web-app designed to make meal prep accessible for …