The Latest Breaking News from FDA

Zosano Pharma Announces Additional Workforce Layoff

The FDA had granted Zosano Pharma Corporation (NASDAQ: ZSAN) a twelve-month extension to April 20, 2023, to resubmit its M207 marketing application.

Benzinga · May 2, 2022

FDA Grants Orphan Drug Designation For IDEAYA's Darovasertib For Uveal Melanoma

The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to IDEAYA Biosciences (NASDAQ: IDYA) for its drug candidate Darovasertib for the treatment of uveal melanoma.

Benzinga · May 2, 2022

U.S. FDA Rejects HUTCHMED's New Drug Application For Surufatinib In Neuroendocrine Tumors

HUTCHMED (China) Limited (Nasdaq: HCM) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for Surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs).

Benzinga · May 2, 2022

QNRX: FDA Clearance To Move QRX003 Clinical Testing Forward; Positive Implications

By M. Marin NASDAQ:QNRX READ THE FULL QNRX RESEARCH REPORT

Benzinga · Apr 30, 2022

U.S. FDA Approves AbbVie's RINVOQ® (upadacitinib) for Ankylosing Spondylitis (AS)

The U.S. Food and Drug Administration (FDA) has approved AbbVie’s (NYSE: ABBV) RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active ankylosing spondylitis (AS) .

Benzinga · Apr 29, 2022

FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA

The FDA has set up June meeting dates to review COVID-19 vaccine submissions, noting that the dates are tentative as none of the submissions are complete.   The agency reserved June 8, 21, and 22 for virtual meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review Moderna Inc (NASDAQ: MRNA) and Pfizer Inc (NYSE: PFE)…

Benzinga · Apr 29, 2022

48 Stocks Moving In Friday's Mid-Day Session

 Gainers Belite Bio Inc. ADR (NASDAQ: BLTE) shares surged 144.8% to $14.69. Belite Bio priced its 6 million ADS IPO at $6 per ADS.

Benzinga · Apr 29, 2022

FDA sets June meetings on COVID vaccines for youngest kids

The Food and Drug Administration has set tentative dates in June to publicly review COVID-19 vaccines for the youngest American children

The Independent UK · Apr 29, 2022

Mid-Morning Market Update: Markets Down; Nasdaq Falls 100 Points

U.S. stocks traded lower this morning, with the Nasdaq Composite dropping around 100 points on Friday.

Benzinga · Apr 29, 2022

AOC Defends Due Process as Colleagues Greenlight Asset Seizure Bill

Plus: Homeland Security's new Disinformation Governance Board, the FDA's menthol ban, and more...

Reason · Apr 29, 2022