FDA Archives - Page 29 of 220

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FDA Approves Merck’s Blockbuster Cancer Drug For Type Of Gastric Cancer

November 17, 9:42 AM

The FDA has approved Merck & Co Inc's (NYSE: MRK) Keytruda, an anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)

MRK

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FDA Approves AstraZeneca’s Truqap/Faslodex Combo Therapy For Breast Cancer, Competes With Gilead’s Drug

By Vandana Singh

November 17, 8:46 AM

FDA approves AstraZeneca Plc's (NASDAQ: AZN) Truqap (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or

AZN

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FDA
News

Astrazeneca Announced Truqap Approved In US For HR+ Breast Cancer

By Charles Gross

November 17, 6:12 AM

AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or

AZN

2 minute read

Merck’s Gefapixant Under FDA Lens: Advisory Committee To Discuss Chronic Cough Drug’s Future

By Vandana Singh

November 16, 1:26 PM

The FDA's Pulmonary-Allergy Drugs Advisory Committee

MRK

1 minute read

FDA Approves Bristol-Myers’ Lung Cancer Drug Acquired Via $4B Turning Point Deal: Competes With Roche, Merck, AstraZeneca

By Vandana Singh

November 16, 7:48 AM

The FDA approved Bristol Myers Squibb And Co's (NYSE: BMY) Augtyro (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small

AZN

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Scilex Holding Company Announces Issuance Of New Patent In The U.S. For Its Lead Commercial Product ZTlido For A Method Of Relieving Pain Through The Application Of A Lidocaine-Containing Patch

By Benzinga Newsdesk

November 15, 10:04 AM

Scilex Holding Company (NASDAQ:SCLX, "Scilex" or "Company")))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute

SCLX

3 minute read

FDA
News

3D Systems Receives FDA Clearance For NextDent Base

By Benzinga Newsdesk

November 15, 9:31 AM

Third-generation material for printing removable dentures offers high break resistance, accurate printing, and repeatable results Material part of company's portfolio of 30 unique NextDent resins – the largest

DDD

1 minute read

Why is Liver Disease Focused Chemomab Stock Trading Higher Today?

By Vandana Singh

November 15, 9:29 AM

Chemomab Therapeutics Ltd (NASDAQ: CMMB) shares are trading higher after the FDA granted CM-101 Fast Track designation for adult patients of primary sclerosing cholangitis (PSC),

CMMB

2 minute read

Ascendis Pharma Resubmits NDA For TransCon PTH To The US FDA

By Benzinga Newsdesk

November 15, 9:11 AM

Ascendis Pharma A/S (NASDAQ:ASND) today announced that it has resubmitted its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adults with hypoparathyroidism to the U.S. Food &

ASND

2 minute read

Solid Biosciences Announces IND Clearance By FDA For Duchenne Muscular Dystrophy Gene Therapy Candidate SGT-003

By Benzinga Newsdesk

November 14, 5:39 PM

– Planning to initiate Phase 1/2 trial in pediatric DMD Patients – – First cohort to study patients 4 to < 6 years of age –CHARLESTOWN, Mass., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Solid Biosciences Inc.

SLDB