Outset Medical announces resolution of FDA warning letter
Outset Medical (OM) announced it has been notified by the FDA that all issues cited in a warning letter the company received in July of 2023 ...
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
STAT1d
The FDA must remove an unnecessary barrier to the use of clozapine for treatment-resistant schizophrenia
If the FDA follows an advisory committee’s vote, it can potentially be a transformative step in the delivery of mental health ...
Achieve Life Sciences Announces Positive Outcome of Second Data Safety Monitoring Committee Review for the ORCA-OL Clinical Trial
No Safety Concerns Identified by DSMC in the ORCA-OL Long-Term Exposure TrialAchieve Reiterates Planned Cytisinicline NDA Submission in Q2 ...
Renal & Urology News14d
Nasal Spray Formulation of Bumetanide Under FDA Review
The analysis also showed greater variability in absorption with the oral form (>40%) compared with the nasal and IV forms (27%). The onset of sodium excretion was found to be faster with nasal ...
TheDerrick.com16d
Leverkusen signs midfielder Emiliano Buendia on loan from Aston Villa
LEVERKUSEN, Germany (AP) — Bayer Leverkusen has signed Argentine offensive midfielder Emiliano Buendia on loan from Aston Villa to compensate for the injured Martin Terrier. The defending ...
C&EN22d
50 new drugs received FDA approval in 2024
C&EN’s tabulation follows approvals from the FDA’s Center for Drug Evaluation and Research; therefore, it does not include blood products, gene therapies, vaccines, and other therapies that ...
cnbctv1822d
Laurus Labs' US arm gets Form 483 from FDA after 'adverse experience' probe
Drug firm Laurus Labs Ltd on Wednesday (January 22) said its wholly-owned foreign subsidiary Laurus Generics Inc (LGI), based in Berkeley Heights, New Jersey, has received a Form 483 from the US Food ...
NBC News23d
Federal regulations paused, halting FDA's proposed ban on formaldehyde in hair products
Not all chemical hair relaxers include the chemical, but many include ingredients that can release formaldehyde when heated, the FDA said in 2024. Over the years, an increasing number of studies ...
Newsweek23d
FDA Approves Nasal Spray for Depression
However, it had to be used in conjunction with an oral medication. The FDA has now expanded its approval to include the standalone use of the nasal spray for adults with treatment-resistant major ...
CNN23d
FDA approves standalone use of J&J’s ketamine-derived depression treatment
The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the ...
Popular Science23d
FDA approves first-of-its-kind nasal spray for severe depression
Johnson & Johnson has announced the FDA’s approval of a first-of-its-kind, esketamine nasal spray called Spravato for the standalone treatment of major depressive disorder (MDD), PTSD ...