FDA Archives - Page 96 of 220

1 minute read

Incyte Would Now Compete With Merck, Pfizer As Its Skin Cancer Treatment Scores FDA Accelerated Approval

March 23, 7:39 AM

The FDA granted accelerated approval to Incyte Corporation’s (NASDAQ:INCY) Zynyz (retifanlimab-dlwr) for adult patients with metastatic or recurrent locally advanced Merkel cell…

INCY

1 minute read

FDA Adcomm Says Benefit-Risk Profile Favor Biogen’s Tofersen For Inherited Neuro Disorder

By Vandana Singh

March 23, 7:12 AM

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 9 yes – 0 no, indicating sufficient evidence showing…

BIIB

4 minute read

Reported Late Wednesday March 22, Biogen Provides Update On FDA Advisory Committee Meeting On Tofersen For SOD1-ALS; The FDA Is Continuing Its Review Of Tofersen With A Prescription Drug User Fee Act Action Date Of April 25, 2023

By Happy Mohamed

March 23, 12:41 AM

Biogen Inc. (NASDAQ:BIIB) announced today the outcome of the U.S.

BIIB

3 minute read

Reported Late Wednesday March 22, Cidara Therapeutics And Melinta Therapeutics Announce FDA Approval Of REZZAYO For The Treatment Of Candidemia And Invasive Candidiasis

By Happy Mohamed

March 23, 12:31 AM

– REZZAYO is a novel, once-weekly, next-generation echinocandin indicated for the treatment of candidemia and invasive candidiasis in adults with limited or no alternative treatment options – – REZZAYO

CDTX

1 minute read

Sandoz Receives U.S. FDA Approval For Biosimilar Hyrimoz High-concentration Formulation; Intends To Launch Hyrimoz Citrate-free Hcf In Us On July 1, 2023

By Happy Mohamed

March 21, 2:51 PM

- Reuters

NVS

4 minute read

Psyched: 22 States With Reform Bills, Ketamine Therapy Services Today, Oscars On Shrooms & More

By Lara Goldstein

March 20, 5:11 PM

Psychedelics Reform Update: 22 States Where Proposals Are Being Discussed & Local Moves Considered

BRAXF

1 minute read

U.S. FDA Staff Says Risks Associated With Biogen’s Tofersen Are Acceptable To The Patient Population, Would Not Preclude Approval

By Happy Mohamed

March 20, 9:18 AM

- Briefing Docs

BIIB

2 minute read

Cue Health Receives FDA Emergency Use Authorization For Molecular Mpox Test

By Happy Mohamed

March 20, 9:16 AM

Authorized to be used in professional point-of-care settings, the nucleic acid amplification test can detect mpox virus and deliver results in 25 minutes Cue Health ("Cue") (NASDAQ:HLTH), a healthcare

HLTH

2 minute read

MyMD Pharmaceuticals And Charles River Present Data For Next Generation, Oral TNF-α Inhibitor MYMD-1 In Rheumatoid Arthritis

By Happy Mohamed

March 20, 8:55 AM

Preclinical results showed MYMD-1® significantly reduced histopathological changes and the severity of standard arthritis clinical trial measures compared to placebo; demonstrate future potential to disrupt the TNF-α inhibitor market

CRL

3 minute read

Vaccitech’s VTP-200 Ph 1b/2 Study Demonstrates Tolerability And Immunogenicity Profile At Interim Analysis In Women With Low-Grade Human Papillomavirus-Related Cervical Lesions

By Happy Mohamed

March 20, 8:03 AM

VTP-200 was generally well-tolerated with no product-related serious adverse events (SAEs) Interim data showed encouraging initial immunogenicity results, particularly in relation to the E1, E2 and E6 antigens used in

VACC