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.

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.

Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.

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.

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 ...

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,

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 ...

(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 ...

A D.C. drugmaker is fighting the FDA on multiple fronts, from trying protect its intellectual property from generic competition to battles over getting more drugs to market.

DiaMedica's DM199 shows promise for Acute Ischemic Stroke, but caution is advised due to low market cap and trial outcome uncertainties. See more on DMAC here.

Bioxyne lifts revenue 77% QoQ; Radiopharm listed on the Nasdaq in the December quarter; Tryptomine hits key milestones; Quarterly season is nearing its end, triggering a rush from

Several ASX-listed companies are undertaking phase III clinical trials, the critical final stage before potential regulatory approval. ... Read More The post Phase III Trials: It’s crunch time for these ASX health stocks appeared first on Stockhead.