Atara to cut 50% of workforce amid FDA woes
Atara Biotherapeutics (NASDAQ:ATRA) has announced plans to cut around 50% of its workforce, just a little over a week after it said the FDA had declined to approve its immunotherapy Ebvallo. The biotech company said it expects to recognize approximately $7.
FDA accepts Teva, Alvotech BLAs for Simponi biosimilars
Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review of the applications is expected to by completed in Q4 2025, according to a statement.
Taysha Gene Therapies Is Showing Promise For Rett Syndrome
Taysha Gene Therapies offers hope for Rett syndrome with innovative treatment, strong trial results, and promising regulatory path. See more on TSHA stock here.
Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1,
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Elicio Therapeutics Receives Supportive FDA Feedback for ELI-002 Phase 3 Study Design, Gains Momentum for Cancer Immunotherapy Development
Received supportive FDA feedback on key elements of the potential ... Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio Therapeutics” or “Elicio”), a clinical-stage biotechnology company ...
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J&J Seeks FDA Nod for Non-Muscle Invasive Bladder Cancer Drug
Johnson & Johnson JNJ has initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat certain patients with non-muscle invasive ...
Incyte, Syndax get FDA okay for 9 mg, 22 mg Niktimvo vials
Incyte (NASDAQ:INCY) and Syndax Pharmaceuticals (SNDX) have received FDA approval for their drug Niktimvo in 9 mg and 22 mg vial sizes. Niktimvo was approved in August 2024 for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg,
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FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
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FDA Approves AstraZeneca's Calquence For Patients With Untreated Mantle Cell Lymphoma
(RTTNews) - AstraZeneca (AZN), on Friday, announced that the FDA has approved CALQUENCE in ... author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew ...
Why Kazia Therapeutics (KZIA) Is Among the Best Australian Stocks to Buy Now?
We recently compiled a list of the 10 Best Australian Stocks to Buy Now. In this article, we are going to take a look at where Kazia Therapeutics Limited (NASDAQ:KZIA) stands against other best Australian stock to buy now.
89bio stock rallies 40% amid data for rival MASH drug
Shares of 89bio (NASDAQ:ETNB) were up 40% Monday afternoon, stoked by positive data for Akero Therapeutics' (NASDAQ:AKRO) drug efruxifermin in the treatment of compensated liver cirrhosis due to MASH.
Vanda Pharmaceuticals seeks FDA nod for motion sickness drug
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA), a pharmaceutical company with a market capitalization of $256.56 million and impressive gross profit margins of 93.62%, disclosed through a social media post that it has submitted a new drug application to the U.