FDA Archives - Page 98 of 220

1 minute read

Roivant Announces Phase 3 Trial Of VTAMA Achieved Primary Endpoint And All Secondary Endpoints

March 15, 7:46 AM

46.4% of subjects receiving VTAMA cream, 1% achieved the primary endpoint of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) response of clear (0) or almost clear (1) with at

ROIV

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FDA
News

Pfizer and BioNTech On Tuesday Received U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years

By Charles Gross

March 15, 6:34 AM

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced Tuesday that the U.S.

BNTX

5 minute read

Reported Late Tuesday March 14, Deciphera Pharmaceuticals Announces QINLOCK Included In NCCN Guidelines For The Treatment Of Second-Line GIST Patients And FDA Grants Breakthrough Therapy Designation For QINLOCK In Second-Line GIST Patients With Mutatio…

By Happy Mohamed

March 15, 12:48 AM

– NCCN Guidelines Include QINLOCK as a Preferred Regimen for Second-Line GIST Patients Intolerant to Sunitinib –

DCPH

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Data For Pfizer’s COVID-19 Drug Shows No Possible Association With Infection Rebound

By Vandana Singh

March 14, 2:48 PM

The FDA dropped in briefing document as the agency’s external advisors meet on Thursday (March 16) to discuss complete approval…

PFE

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Veru Phase 2 Development Of Veru-100 And Zuclomiphene Assets Will Be Paused; Is Reserving Sabizabulin For Clinical Development Only In Infectious Disease Indications, Terminating Phase 3 Veracity Trial Of Sabizabulin In Certain Prostate Cancer Patients

By Happy Mohamed

March 14, 12:36 PM

- Reuters

VERU

2 minute read

Reported Late Monday March 13, Everest Medicines Announces Partner Calliditas Therapeutics Reports Topline Results From Phase 3 NefIgArd Trial Evaluating Nefecon In IgA Nephropathy; Trial Primary Endpoint Was Met With Nefecon

By Happy Mohamed

March 14, 1:10 AM

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that its partner Calliditas Therapeutics AB (NASDAQ:CALT, Nasdaq Stockholm: CALTX)))) ("Calliditas") reported

CALT

1 minute read

Reported Late Monday March 13, Innoviva Announces FDA Advisory Committee Meeting To Review Sulbactam-Durlobactam An Investigational Targeted Antibiotic On April 17, 2023

By Happy Mohamed

March 14, 12:57 AM

Innoviva, Inc. (NASDAQ:INVA) ("Innoviva"), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration's (FDA)

INVA

1 minute read

Acadia Pharma’s Rett Syndrome Drug Becomes First FDA-Approved Treatment

By Vandana Singh

March 13, 10:56 AM

The FDA has approved Acadia Pharmaceuticals Inc’s (NASDAQ:ACAD) Daybue (trofinetide) for Rett syndrome in adult and pediatric patients two years of…

ACAD

2 minute read

Hefty Listing Price Of New Drugs For Cancer, Rare Diseases Put Pressure On Annual Hike For Older Drugs

By Vandana Singh

March 10, 2:10 PM

New branded medicines are coming to market with ever-higher price tags as soon as the first day. Amgen Inc's (NASDAQ: AMGN) lung cancer treatment, Lumakras, carried a hefty price tag of $17,900 per patient monthly when it launched in 2021.

AMGN

2 minute read

FDA Addresses ‘Misinformation’ Concerning Delayed Approval Of Lucira Health’s COVID-19 & Flu Home Test

By Vandana Singh

March 10, 12:51 PM

The FDA provided additional information about the agency’s interactions and decisions regarding the emergency use authorization (EUA) of Lucira Health Inc’s (OTC: LHDXQ)…

LHDX