PharmaTher Provides Update on FDA New Drug Application for Ketamine
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of KETARX™ (Ketamine) to fill the global unmet medical needs for anesthesia, sedation, pain, ...
Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has ...
FiercePharma4h
Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
Scotiabank raises Travere stock target to $32 on FDA update
Scotiabank (TSX:BNS) analyst Greg Harrison increased the price target on Travere Therapeutics (NASDAQ:TVTX) to $32.00, up from the previous $27.00, while retaining a Sector Outperform rating for the ...
Biohaven stock rises following FDA review and Deutsche Bank's buy rating
Shares of Biohaven Ltd. (NYSE: BHVN) climbed 7% as the company announced the FDA's acceptance and Priority Review of its ...
pulmonologyadvisor1d
Nasal Spray Formulation of Bumetanide Under FDA Review
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
Targeted Oncology6d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
Regeneron Gets New FDA Review of Linvoseltamab for Multiple Myeloma
Regeneron, which is seeking FDA approval of linvoseltamab for adults with relapsed/refractory multiple myeloma that has progressed after at least three prior therapies, said the agency set a new ...
BioSpace12d
FDA Approves Vertex’s Journavx as First New Pain Drug in Decades
The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum ...
Acsh.org1d
Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
Why Axsome Therapeutics Stock Is Skyrocketing Today
Shares of Axsome Therapeutics ( AXSM 20.22%) are flying higher on Monday. The company's stock is up 24.7% as of 1:10 p.m. ET, ...
Biohaven Ltd.: Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. Troriluzole demonstrated a 50-70% slowing of SCA disease progression ...