- Spark Newswire

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FDA Accepts AstraZeneca’s sBLA for Imfinzi (durvalumab) in biliary tract cancer (BTC) with Priority Review

Today, 8:40 AM

The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca's (NASDAQ: AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy and granted Priority Review for patients with locally advanced or metastatic biliary tract cancer (BTC).

AZN

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FDA Issues Complete Response Letter (CRL) to Axsome Therapeutics for AXS-07 In Acute Migraine

By Ragothaman Srinivasan

Today, 8:40 AM

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Axsome Therapeutics, Inc. (NASDAQ: AXSM) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

AXSM

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

By Ragothaman Srinivasan

Today, 8:40 AM

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.

IDYA

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

By Ragothaman Srinivasan

Today, 8:40 AM

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).

HCM

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

By Ragothaman Srinivasan

Today, 8:40 AM

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) .

ABBV

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Lyra Therapeutics Presents LYR-210 Positive Data from LANTERN Phase 2 Study for Chronic Rhinosinusitis

By Ragothaman Srinivasan

Today, 8:40 AM

Lyra Therapeutics, Inc. (NASDAQ: LYRA) announced new data from its LANTERN Phase 2 study of LYR-210 in adult patients with chronic rhinosinusitis (CRS) at the 2022 Combined Otolaryngology Spring Meetings (COSM) being held in Dallas, Texas.

LYRA

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U.S. FDA Approves Bristol Myers Squibb’s Camzyos™ (mavacamten) for the Treatment of Adults With obstructive HCM

By Ragothaman Srinivasan

Today, 8:40 AM

Bristol Myers Squibb (NYSE: BMY) announced the U.S.

BMY

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U.S. FDA removes Clinical Hold on Finch’s investigational new drug (IND) application for CP101

By Ragothaman Srinivasan

Today, 8:40 AM

The U.S. Food and Drug Administration (FDA) has removed the clinical hold on Finch Therapeutics Group (NASDAQ: FNCH) investigational new drug (IND) application for CP101 in the prevention of recurrent C. difficile infection (CDI).

FNCH

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U.S. FDA Grants Orphan-Drug Designation for Allogene’s ALLO-605 for multiple myeloma

By Ragothaman Srinivasan

Today, 8:40 AM

Allogene Therapeutics, Inc. (Nasdaq: ALLO) received Orphan-drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its drug candidate ALLO-605 for the treatment of patients with multiple myeloma.

ALLO

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Jasper Therapeutics Presented Updated Data from Phase 1 Clinical Trial of JSP191

By Ragothaman Srinivasan

Today, 8:40 AM

Jasper Therapeutics, Inc., (NASDAQ: JSPR) announced updated efficacy, safety and pharmacokinetic data from its Phase 1 clinical trial of JSP191, in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation.

JSPR