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FDA

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4 minute read
  • Biotech
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Zealand Pharma Announces Oral Presentation Of Phase 2 Data For BI 456906 At The 58th Annual Meeting Of The European Association For The Study of Diabetes September 21

By Benzinga Newsdesk
September 21, 8:50 AM
Press release – No. 6 / 2022 Zealand Pharma Announces Oral Presentation of Phase 2 Data for BI 456906 at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD) BI 456906

ZEAL

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2 minute read
  • Biotech
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PDS Biotech And National Cancer Institute Identify Optimal Patient Group For Advancing PDS0101-Based Triple Combination Program Targeting Advanced HPV-Positive Cancers

By Benzinga Newsdesk
September 21, 8:46 AM
FLORHAM PARK, N.J., Sept. 21, 2022 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (NASDAQ:PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and

PDSB

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3 minute read
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Alaunos Therapeutics Highlights Data From TCR-T Library Phase 1/2 Trial At The CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference; Data To Be Presented On Friday, September 30

By Benzinga Newsdesk
September 21, 8:33 AM
First patient achieved a confirmed partial response with 51.2% tumor regression with TCR-T cell persistence ongoing at 3 months post infusion Sleeping Beauty TCR-T cell therapy had a manageable safety

TCRT

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1 minute read
  • Events
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VBI Vaccines Announces Presentation Of Physician-Initiated Compassionate Use Data Of 3-Antigen Hepatitis B Vaccine At 2022 International HBV Meeting; Presentation Was Monday, Sept. 19

By Benzinga Newsdesk
September 21, 8:05 AM
VBI Vaccines Inc. (NASDAQ:VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced that data from the physician-initiated

VBIV

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1 minute read
  • FDA
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Mapi Pharma Announces Top-Line Results From GA Depot Phase III Trial For Relapsing Forms Of Multiple Sclerosis; Says Study Met Primary Endpoint

By Benzinga Newsdesk
September 21, 8:01 AM
The study met its primary endpoint showing that GA Depot 40 mg statistically significantly reduced the annualized relapse rate (ARR) by 30.1 percent compared to placebo (p=0.0066)

VTRS

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FDA Concludes Oversight Shortcomings After Infant Formula Internal Review

By Vandana Singh
September 21, 7:28 AM
The FDA concluded an internal review of agency actions related to the U.S. infant formula supply.

ABT

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1 minute read
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Fennec Pharmaceuticals Granted FDA Approval For PEDMARK

By Benzinga Newsdesk
September 20, 3:57 PM
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212937

FENC

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2 minute read
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FDA Says No Way To Food Companies Wanting To Get On The CBD Gravy Train

By Maureen Meehan
September 20, 3:56 PM
As several major food makers are champing at the bit to cash in on the CBD food and drinks craze, it seems the FDA is still not down with the program.

BUD

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FDA Says Report Highlights Findings And Recommendations That Will Support Agency’s Ongoing Efforts To Ensure Our Most Vulnerable Population Has Consistent Access To Infant And Specialty Formula Products In Future

By Benzinga Newsdesk
September 20, 3:26 PM
-Dow Jones

ABT

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Merck To Start New Islatravir HIV Trials With Lower Dose After FDA Hold

By Vandana Singh
September 20, 11:24 AM
Merck & Co Inc (NYSE:MRK) will initiate a new Phase 3 program with once-daily islatravir to treat people with HIV-1 infection. …

GILD

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