PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamineTORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- ...

PharmaTher Holdings to resubmit information on ketamine NDA to US FDA by end of February 2025: Toronto Saturday, February 15, 2025, 18:00 Hrs [IST] PharmaTher Holdings Ltd, a spec ...

Ketamine, a dissociative anesthetic, has carved itself a spot in the world of mental health care over the past two decades.

Ketamine, a non-competitive N-methyl-D-aspartate receptor antagonist, has emerged as an effective therapeutic agent for the management of treatment-resistant depression. Repeated treatments with ...

Major depressive disorder (MDD) is a leading cause of disability worldwide, with a significant proportion of patients (10-20%) progressing to treatment-resistant depression (TRD).

(RTTNews) - PharmaTher Holdings Ltd. (PHRM), on Wednesday, provided an update on its New Drug Application or NDA for ketamine, announcing plans to resubmit the necessary information to the FDA by ...

After the rejection of Lykos Therapeutics’ MDMA-based PTSD treatment tempered excitement for psychedelic therapeutics, a ...

The anesthetic ketamine is being hailed as a breakthrough therapy for people with post-traumatic stress disorder (PTSD), treatment-resistant depression and other mood disorders.

Ketamine also has come under increasing scrutiny as a treatment recently, with studies suggesting that for some patients it ...

PharmaTher (PHRRF) announced that the Company is on track to resubmit information to the FDA by end-February 2025. This resubmission, which ...

The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

IntroductionMajor depressive disorder (MDD) is a leading cause of disability worldwide, with a significant proportion of patients (10-20%) progressing ...