FDA Archives - Page 147 of 220

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FDA Committee Voted 8-5 That Known Potential Benefits Do Not Outweigh The Known And Potential Risks Of Sabizabulin. Input Of The Advisory Committee As Part Of Their Review Of The EUA And Render A Decision On The Emergency Use Authorization

November 10, 2:26 AM

Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, announces the results of today's meeting of the U.S.

VERU

2 minute read

AVITA Medical Announces Achievement Of Co-Primary Endpoints In Updated Analysis Of Pivotal Trial Of RECELL System For Soft Tissue Repair

By Benzinga Newsdesk

November 9, 7:51 PM

AVITA Medical, Inc. (NASDAQ:RCEL, ASX: AVH)))), a regenerative medicine company leading the development and commercialization of first-in-class devices and autologous cellular therapies for skin restoration, today

RCEL

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FDA Adcomm Backs AstraZeneca’s 2-In-1 Asthma Inhaler, Only For Adults Being Less Sure For Adolescents, Kids

By Vandana Singh

November 9, 12:04 PM

The FDA’s Pulmonary-Allergy Drugs Advisory Committee has voted 16 to 1 that the data support a favorable benefit-risk assessment for…

AZN

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FDA
News

Novavax Nuvaxovid Covid-19 Vaccine Authorized In The United Kingdom For Use As A Booster In Adults

By Benzinga Newsdesk

November 9, 10:20 AM

Novavax, Inc. (NASDAQ:NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Medicines and Healthcare products

NVAX

3 minute read

Chemomab Presents Clinical Data From Investigator-Initiated Study Showing CM-101 Reduced Inflammatory And Fibrogenesis-Related Biomarkers In Patients With Severe Lung Injury Derived From Covid-19

By Benzinga Newsdesk

November 9, 9:12 AM

─New Findings Demonstrate CM-101's Anti-Inflammatory and Anti-Fibrotic Effects Are Highly Relevant to Inflammatory Lung Diseases─ TEL AVIV, Israel, Nov. 9, 2022 /PRNewswire/ -- Chemomab Therapeutics, Ltd.

CMMB

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FDA
News

AstraZeneca Announced PT027 Recommended by FDA Advisory Committee as New Rescue Treatment for Asthma

By Charles Gross

November 9, 5:47 AM

The Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 16 to 1 that the data support a favourable benefit risk assessment for the use of PT027 (albuterol/budesonide) for the treatment of asthma in people aged 18 years and older.

AZN

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“Rafael Pharmaceuticals Has Received A Notice Of Allowance For Its U.S. Patent Application 17/261,237 Titled ‘Therapeutic Methods And Compositions For Treating Pancreatic Cancer Using 6,8-BIS-BENZYLTHIO-OCTANOIC ACID'” – USPTO

By Benzinga Newsdesk

November 8, 12:39 PM

https://patentcenter.uspto.gov/#!/applications/17261237/ifw/docs

RFL

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FDA
News

Ionis Highlights Data From GSK’s Phase 2b Clinical Study Of Bepirovirsen

By Benzinga Newsdesk

November 8, 12:06 PM

onis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that GSK presented positive end of study data from the Phase 2b B-Clear study of bepirovirsen (formerly IONIS-HBVRx), an investigational antisense

IONS

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“Inseego Granted U.S. Patent #11490812 For ‘Systems And Methods For Monitoring And Detecting Symptoms Of Infectious Conditions’. Mentions HIV And Covid. Bounce Chart. Search 11490812” – USPTO

By Benzinga Newsdesk

November 8, 11:47 AM

Patent Public Search | USPTO

INSG

5 minute read

Sustained Patient Response To KRYSTEXXA Injection With Methotrexate Compared To KRYSTEXXA Alone Shown Through Month 12 In MIRROR Randomized Controlled Trial

By Benzinga Newsdesk

November 8, 11:01 AM

-- Month 12 results from MIRROR randomized controlled trial to be featured on Nov. 13, 11:45 a.m. EST during plenary session at the American College of Rheumatology Convergence 2022 -- -- Imaging analyses visualize

HZNP