Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the ...
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...
The IRA’s price controls discourage post-marketing research. The potential benefits from expanding access to the drug to ...
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FDA lifts clinical hold on Amylyx’s Phase I ALS trialThis is the latest venture for Amylyx into the ALS field after its previous therapy Relyvrio was pulled from the market in ...
The FDA didn't approve the therapy in EBV-positive post-transplant lymphoproliferative disease due to findings at a third-party manufacturing facility.
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FDA set to reduce drug registration timelineTHE Food and Drug Administration (FDA) said Friday that it is set to release a new administrative order that would reduce the timeline of drug registration, especially among imported drugs that have ...
With $10 million in new funding, Teal Health co-founder Kara Egan shares how her health care startup intends to reach its first patients.
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
The process of getting screened for cervical cancer is quite intimidating. It’s the once-a-year, sometimes life-changing ...
Atara Biotherapeutics said Thursday that the FDA has turned down its request to start selling its Ebvallo drug across state lines in a complete response letter.
TransMedics' stock remains under pressure after a weak third quarter, reduced Q4 guidance, the exit of the company's CFO, and ...
Atara, Pierre Fabre hit a hurdle with Ebvallo in the US courtesy of manufacturing plant's shortfalls
As partners Atara Biotherapeutics and Pierre Fabre Laboratories work to grow the reach of their novel T-cell immunotherapy ...
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