FDA Archives - Page 53 of 220

2 minute read

Psilocybin For IBS Gets FDA Nod To Begin Clinical Trials At Mass. General Hospital

July 13, 3:48 PM

Tryp Therapeutics’ (OTCQB: TRYPF) latest Investigational New Drug (IND) application was approved by the FDA, enabling the company to begin Phase 2a clinical trials at the Massachusetts General Hospital (MGH) on the effects of psilocybin-assisted psychotherapy for adults with Irritable B

TRYPF

1 minute read

First Birth Control Pill For OTC Use In US Gets FDA Approval – Perrigo’s Opill

By Vandana Singh

July 13, 11:58 AM

Perrigo Company plc (NYSE: PRGO) shares are trading higher after the FDA approved the company's Opill, a progestin-only daily oral contraceptive for over-the-counter

PRGO

2 minute read

YouTube Stars’ Energy Drink Under FDA Review After Senate Majority Leader Raises Concern

By Vandana Singh

July 13, 9:26 AM

The FDA is currently assessing concerns raised by Senate Majority Leader Chuck Schumer about the high caffeine content in a popular energy drink called Prime Energy. The drink, founded by YouTube stars Logan Paul and KSI, is allegedly being marketed to children and teens.

CELH

3 minute read

Moleculin Announces Publication Of Data From Successful European Phase 1 Trial Evaluating Annamycin As Single Agent Treatment Of Relapsed Or Refractory Acute Myeloid Leukemia

By Happy Mohamed

July 13, 8:42 AM

Data published in peer-reviewed British Journal of Cancer Research No evidence of cardiotoxicity in any subject treated in this study, including up to 16 subjects whose cumulative anthracycline dose (Annamycin included)

MBRX

2 minute read

Meta Teams Up With LegitScript To Certify CBD Products & Websites, Opening New Advertising Avenues

By Joana Scopel

July 12, 3:48 PM

LegitScript, renowned in e-commerce and payment sector certification and monitoring, has formed a partnership with Meta Platforms Inc (NASDAQ: META) to provide certification for specific topical, non-ingestible CBD products and correspon

Takeda Withdraws FDA Application For Dengue Vaccine Candidate On Data Disagreement

By Vandana Singh

July 12, 8:32 AM

Takeda Pharmaceutical Co Ltd (NYSE: TAK) said on Tuesday that it was voluntarily

SNY

1 minute read

FDA
News

AstraZeneca Announced Enhertu Approved In China As The First HER2-Directed Therapy For Patients With HER2-Low Metastatic Breast Cancer

By Charles Gross

July 12, 6:37 AM

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in China as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-)

AZN

3 minute read

Incyte Announces Topline Results From Phase 3 Trial Evaluating Ruxolitinib Cream In Children With Atopic Dermatitis

By Happy Mohamed

July 11, 4:06 PM

Phase 3 TruE-AD3 Study met its primary endpoint Incyte (NASDAQ:INCY) today announced positive topline results from its randomized, vehicle-controlled, pivotal Phase 3 TRuE-AD3 study evaluating the safety and efficacy of

INCY

1 minute read

Why Are Tandem Diabetes Shares Gaining Today?

By Vandana Singh

July 11, 2:44 PM

Tandem Diabetes Care Inc (NASDAQ: TNDM) shares are trading higher after the company received FDA approval for the Tandem Mobi insulin pump for people with diabetes age 6 and up, expanding the company's

TNDM

1 minute read

Johnson & Johnson’s Unit Recalls Certain Electrosurgical Tools Due Risk Of Burn Injuries

By Vandana Singh

July 11, 1:08 PM

The FDA classified the recall of certain electrosurgery tools manufactured by a Johnson & Johnson (NYSE: JNJ) unit as the most serious, saying their use could lead to injuries or death.

JNJ