FDA Archives - Page 39 of 220

2 minute read

Natera Submits First Premarket Approval Module To The FDA For Signatera

October 2, 9:01 AM

Lays groundwork for multiple submissions across cancer types, starting with CDx label in bladder cancerNatera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA testing, today announced the submission of the first

NTRA

2 minute read

Nobel Prize Honors Scientists Behind mRNA Vaccines Against Covid-19

By Piero Cingari

October 2, 8:55 AM

Discover the remarkable journey of Nobel Prize laureates Kariko and Weissman, who transformed medicine with mRNA vaccines, and the financial impact on Moderna and Pfizer stocks.

BNTX

3 minute read

Mirum Pharmaceuticals Announces Phase 3 RESTORE Study Results Evaluating Chenodal In Patients With Cerebrotendinous Xanthomatosis

By Benzinga Newsdesk

October 2, 8:33 AM

- Primary endpoint met (p<0.0001); 20-fold difference in urine bile alcohols- First and only prospective, controlled clinical trial in CTX- Plasma cholestanol endpoint met (p=0.0083), the driver of poor outcomes in

MIRM

1 minute read

EXCLUSIVE: Alzamend Neuro To Start Next-Gen Therapy Study For Bipolar Disorder

By Vandana Singh

October 2, 7:30 AM

Alzamend Neuro Inc (NASDAQ: ALZN) received the FDA's "Study May Proceed" letter to initiate study AL001-BD01, a Phase 2A clinical study of AL001 for bipolar disorder type 1. The company expects the first patient to be dosed in the first quarter of 2024.

ALZN

1 minute read

Amicus Therapeutics Drug Scores FDA Approval For Rare Inherited Pompe Disease

By Vandana Singh

September 28, 12:41 PM

The FDA has approved Amicus Therapeutics' (NASDAQ: FOLD) Pombiliti (cipaglucosidase alfa-atga)+Opfolda (miglustat) 65mg capsules for Pompe disease.

FOLD

3 minute read

Amicus Therapeutics Announces FDA Approval And Launch Of New Treatment For Pompe Disease

By Benzinga Newsdesk

September 28, 10:43 AM

Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) Approved in ERT-Experienced Adults First and Only Two-Component Therapy for Eligible Adults Living with Late-onset Pompe DiseaseAmicus

FOLD

3 minute read

Biomea Fusion Announces FDA And Health Canada Clearance Of The Expansion Cohorts Of The Ongoing COVALENT-111 Phase II Study

By Benzinga Newsdesk

September 28, 8:32 AM

The FDA and Health Canada have cleared the initiation of the expansion portion of COVALENT-111, which will evaluate BMF-219 administered at 100 mg and 200 mg, with dosing durations up to 12 weeks in type 2 diabetes

BMEA

1 minute read

FDA Advisory Panels Gives Thumbs Down To BrainStorm’s Lead Therapy

By Vandana Singh

September 28, 8:20 AM

The FDA's Cellular, Tissue and Gene Therapies Advisory Committee meeting reviewing BrainStorm Cell Therapeutics Inc's (NASDAQ: BCLI) NurOwn application voted that NurOwn did not demonstrate substantial evidence of effectiveness for treatment of

BCLI

2 minute read

EXCLUSIVE: Cannabis Catalysts Praise SAFER Momentum, Plus State Market Prospects

By Lara Goldstein

September 27, 4:53 PM

The cannabis industry is poised for some serious growth owing to the historic clearance of the SAFER Banking Act by the

TCNNF

4 minute read

U.S. FDA Approves Subcutaneous Administration Of Takeda’s ENTYVIO For Maintenance Therapy In Moderately To Severely Active Ulcerative Colitis

By Happy Mohamed

September 27, 4:27 PM

− ENTYVIO Is the Only FDA-Approved Ulcerative Colitis Biologic That Offers the Choice of Intravenous or Subcutaneous Maintenance Therapy Takeda ((TAK) today announced that the U.S. Food and Drug

TAK