Q2 2025 Management View CEO Matthew Kapusta highlighted that "the first half of 2025 has been tremendously productive for the company as we advance AMT-130 towards potentially becoming the first ...

On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its ...

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

Replimune (NASDAQ:REPL) stock surges as Cantor Fitzgerald upgrades, citing improved odds for approval of its lead drug after an FDA leadership change. Read more here.

The FDA has accepted for priority review the resubmitted BLA for tabelecleucel to treat patients 2 years of age and older with EBV+ PTLD who have received at least 1 prior therapy.

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

The Baloch Liberation Army (BLA) has asserted responsibility for a series of simultaneous armed operations throughout various ...

As of June 30, 2025, the Company had cash, cash equivalents and investment securities of $377.0 million. The Company expects that cash, cash equivalents and investment securities will be sufficient to ...

Vera Therapeutics' Phase 3 data on atacicept sparks optimism for IgAN treatment, but competition and market challenges may ...

While the BLA’s funding sources remain unclear, analysts suggest multiple revenue streams, including illicit activities such as extortion, smuggling and drug trafficking.