FDA Archives - Page 121 of 220

1 minute read

Kamada Announces Submission Of Application To US FDA To Manufacture CYTOGAM At Company’s Facility In Israel

January 4, 8:01 AM

FDA Approval Currently Expected by Mid-2023 Sales of CYTOGAM® Highest Among Four IgG Products Acquired in November 2021, with Gross Margins Over 50% Ability to Manufacture CYTOGAM at Kamada's Facility to

KMDA

1 minute read

Why Lucira Health Shares Are Trading Higher Today

By Sean Torres

January 3, 1:56 PM

Lucira Health, Inc. (NASDAQ: LHDX) shares are surging higher on Tuesday after the company announced it submitted an Emergency Use Authorization application to the FDA for over-the-counter use of its COVID-19 & Flu test.

LHDX

1 minute read

Traders May Be Circulating A Report From Jan 2, 2023, Titled ‘Medicare May Not Cover 2 Alzheimer’s Drugs Poised For Approval’ – Politico

By Happy Mohamed

January 3, 12:44 PM

https://subscriber.politicopro.com/article/2023/01/medicare-may-not-cover-two-alzheimers-drugs-poised-for-approval-00075332 CMS currently requires patients be enrolled in a randomized trial to pay for a certain class of

BIIB

3 minute read

European Medicines Agency Validates Marketing Authorization Application For Trodelvy For Pre-Treated HR+/HER2- Metastatic Breast Cancer

By Benzinga Newsdesk

January 3, 9:33 AM

– Application Based on Statistically Significant and Clinically Meaningful Overall Survival and Progression-Free Survival Results from the Phase 3 TROPiCS-02 Study – – Supplemental Biologics License

GILD

1 minute read

Lucira Health Submits EUA For Over-The-Counter Use Of Its COVID-19 & Flu Test

By Benzinga Newsdesk

January 3, 8:03 AM

Lucira Health, Inc. (NASDAQ:LHDX) ("Lucira Health" or "Lucira"), a medical technology company, announced that it submitted an Emergency Use Authorization application to the FDA for OTC use of its

LHDX

1 minute read

FDA
News

Center For Drug Evaluation Of China National Medical Products Administration Accepted A Supplemental Biologics License Application For Tislelizumab

By Benzinga Newsdesk

December 30, 10:18 AM

-Reuters

BGNE

1 minute read

ONCOC4 Announces First Patient Dosed In Preserve-004, A Phase 2 Clinical Trial Of Onc-392 In Combination With Keytruda In Patients With Platinum-resistant Ovarian Cancer

By Benzinga Newsdesk

December 30, 9:31 AM

- Reuters

MRK

2 minute read

Silo Pharma Announces Study Results Of SPU- 21 For Arthritis; Co. Reports ‘SPU-21 effective in controlling arthritis progression’

By Benzinga Newsdesk

December 30, 9:11 AM

Silo Pharma, Inc. (NASDAQ:SILO) (“the Company”), a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research, today announced positive interim data

SILO

1 minute read

FDA Approves MediWound’s NexoBrid For Burn Treatment

By Vandana Singh

December 30, 6:26 AM

The FDA has approved MediWound Ltd’s (NASDAQ:MDWD) NexoBrid (anacaulase-bcdb) to remove eschar in adults with deep partial-thickness and/or full-thickness thermal burns.…

MDWD