FDA News Monitoring

Pharma sector grappling with new realities at home and overseas 

In the new year, the Indian pharmaceutical sector will have to grapple with new realities, at home and overseas.  On home ground, the updated Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024, for example, will see tighter implementation, …

Axsome Aims for FDA Filing in Alzheimer’s Agitation Despite Mixed Bag of Phase 3 Data

Agitation caused by Alzheimer’s disease currently has one FDA-approved therapy, but that drug brings serious safety risks. An Axsome Therapeutics drug has mixed results from its latest slate of clinical tests in this indication, but company executives say …

STAT+: Axsome to send Alzheimer’s disease drug to FDA, despite mixed Phase 3 results

Axsome Therapeutics is moving ahead with plans to submit its Alzheimer’s disease treatment for Food and Drug Administration approval despite mixed results from two new clinical trial readouts.  Axsome, which is based in New York, announced Monday that its …

FDA Approval Insights: Zanidatamab in Pretreated, HER2+ Biliary Tract Cancer

Welcome to OncLive On Air®! I’m your host today, Jax DiEugenio. OncLive On Air is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print …

Ocular Implants Market Size, Share & Forecast To 2033

(MENAFN- Straits Research) Introduction Eye diseases are conditions that affect the eyes, leading to vision impairment or loss. Common types include cataracts, glaucoma, macular degeneration, diabetic retinopathy, and retinal diseases. Treatments vary …

3 Extreme Policies of the Biden Administration

As the Biden administration winds to a close, the time has come to examine President Joe Biden’s record. Certain policy decisions stand out as colossal mistakes, while others are noteworthy for their extremism. The following are three policy areas where …

The FDA's New 'Best By' Food Label Strategy Will Save Americans Millions and Reduce Waste

The FDA’s recent announcement about the 2022 Food Code might seem like dry regulatory news, but it holds significance for how consumers approach food waste. For years, Americans have tossed billions of pounds of food based on misunderstood labels like “ …

14 Of The Biggest Sausage Recalls Throughout US History

Sausages are one of the most accessible meat products out there, and as a result, they're everywhere. Head into any large supermarket, and you'll have dozens of brands and options to choose from, in a variety of shapes, sizes, and flavors. …

Dalton couple to premiere documentary on possible impacts of food dyes

Each day, millions of Americans consume artificial dyes in their food and drink, and most of them notice no major side effects. But Dalton resident Whitney Cawood said when her son, now 6, was an infant, they noticed that the sweet-tempered child would …

Drug Naltrexone has increased in popularity significantly 30 years after FDA approval

Bristol Myers Squibb Wins FDA Nod for Injectable Version of Blockbuster Cancer Drug

Bristol Myers Squibb has won FDA approval for an injectable version of its blockbuster cancer immunotherapy Opdivo, a regulatory decision that gives patients a more convenient dosing option and provides the pharmaceutical giant a new way to fend off coming …

'Crazy' - advocates question government's vaping plan

Photo: Unsplash The government's plan for smokers to swap their cigarettes for free vapes in a bid to quit smoking has come underfire from respiratory advocates. Associate Health Minister Casey Costello said vaping starter kits would be supplied to …

More than 20 items recalled by FDA for December. See full list here

Put those chips down again! Some snacks you just shouldn't eat for the time being. It's been a challenging year for consumers. Each month, the U.S. Food and Drug Administration has halted food-and-drug related items for purchase. Most of the …

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 …

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 …

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 …

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 …

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 …

Acute Lymphocytic Leukemia Treatment Market 2034: Clinical Trials, EMA, PDMA, FDA Approvals, Medication, Epidemiology, ...

(MENAFN- GetNews) "Acute lymphocytic leukemia Market"Acute lymphocytic leukemia companies working in the market are Pharmacyclics (AbbVie), Gamida cell, Bristol-Myers Squibb, Autolus Therapeutics, Roche, Servier, BioLine Rx, Sanofi, Jazz …

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 …

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 …

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 …

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 …

IBN Technologies Pioneers Financial Innovation with Cutting-Edge Solutions

Discover how IBN Technologies is transforming finance with AI, cloud solutions, and more to drive business success. MIAMI, FL, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- Miami, Florida – 31 December 2024 – As businesses face …

IBN Technologies Expands Opportunities for Small Businesses through Outsourcing Accounting Services

Discover how IBN Technologies is transforming finance with AI, cloud solutions, and more to drive business success. MIAMI, FL, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- Small businesses across the USA face growing challenges in …

IBN Technologies Emerges as the Go-To Partner for Outsource Bookkeeping Services for Small Businesses

Discover how IBN Technologies is becoming the trusted partner for small businesses seeking reliable and cost-effective outsourced bookkeeping services. MIAMI, FL, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- IBN Technologies, a global …

Upcycled food products Market Size Expected to Reach $97 Billion by 2031

The upcycled food products market size was valued at $53.7 billion in 2021, and is estimated to reach $97 billion by 2031, growing at a CAGR of 6.2% WILMINGTON, DE, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- The upcycled food …

GMO Testing Market Size Projected to Reach $6.2 Billion by 2031: ALS Limited, Bio-Rad Laboratories, EnviroLogix

The GMO Testing Market Size was valued at $3.9 billion in 2021, and is estimated to reach $6.2 billion by 2031, growing at a CAGR of 4.8% from 2022 to 2031 WILMINGTON, DE, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- The growth of GMO …

Lipase Food Enzymes Market Size Expected to Reach $787.6 Million by 2031

The lipase food enzymes market size was valued at $417.40 million in 2021, and is estimated to reach $787.6 million by 2031, growing at a CAGR of 6.8% WILMINGTON, DE, UNITED STATES, December 31, 2024 /⁨EINPresswire.com⁩/ -- A type of digestive …