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FDA Approves Carvykti for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy
HORSHAM, PA (April 5, 2024)– Johnson& Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved Carvykti® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Abecma for Triple-Class Exposed Relapsed or Refractory Multiple Myeloma After Two Prior Lines of Therapy
PRINCETON, N.J.,& CAMBRIDGE, Mass.--(BUSINESS WIRE) April 05, 2024 -- Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 5, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves First Prescription Digital Therapy for Major Depression
THURSDAY, April 4, 2024 -- The U.S. Food and Drug Administration (FDA) has cleared the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms.The approval is for Rejoyn, a six-week... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 4, 2024 Category: Pharmaceuticals Source Type: news

FDA Approves First Prescription Digital Therapy for Major Depression, Rejoyn
THURSDAY, April 4, 2024 -- The U.S. Food and Drug Administration (FDA) has cleared the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. The approval is for Rejoyn, a... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - April 4, 2024 Category: Pharmaceuticals Source Type: news

Siemens Healthineers gets FDA nod for Mammomat B.brilliant system
The Mammomat B.brilliant mammography platform by Siemens Healthineers has received 510(k) clearance by the U.S. Food and Drug Administration (FDA). Image courtesy of Siemens Healthineers,Siemens Healthineers' Mammomat B.brilliant mammography system has received 510(k) clearance by the U.S. Food and Drug Administration (FDA). Mammomat B.brilliant is the first completely redesigned mammography platform in over a decade, the company said. The clearance includes elements that involve full-field digital mammography, 2D breast imaging, breast biopsy, and titanium contrast-enhanced mammography. Additionally, Siemens recently f...
Source: AuntMinnie.com Headlines - April 4, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

Fujifilm, Brainlab partner on distribution of Arietta
Fujifilm Healthcare Americas and Brainlab have inked a partnership that sets Brainlab as the exclusive U.S. distributor of Arietta Precision Ultrasound for neurosurgery applications to be used with Brainlab's surgical navigation systems. Brainlab will distribute Arietta Precision as a standalone product alongside and with its Ultrasound Navigation software. The company said that this offering is expected to be cleared by the U.S. Food and Drug Administration (FDA) and available in the U.S. in mid-2024. The combination of these technologies will offer neurosurgeons real-time insights through live intraoperative ultrasoun...
Source: AuntMinnie.com Headlines - April 4, 2024 Category: Radiology Authors: AuntMinnie.com staff writers Tags: Industry News Source Type: news

The rise of theranostics: Part 2 -- Moving into communities
A decade ago, only a few radiopharmaceutical agents were used to help treat cancer patients. That has changed and the field of theranostics is expanding rapidly in various ways, as described in part 1 of AuntMinnie.com's series on the rise of theranostics. However, few freestanding theranostics centers exist today. Even if some private urology, radiation oncology practices, or radiologist groups are building the ability to perform theranostics, experts are cautious about patient management, radiation safety, and the risk of unnecessary imaging. They're also mindful of the multiple dedicated teams required to build a thera...
Source: AuntMinnie.com Headlines - April 4, 2024 Category: Radiology Authors: Liz Carey Tags: Practice Management Radiation Oncology/Therapy Nuclear Medicine Medicolegal Genitourinary Radiology Source Type: news

A.L.S. Drug Relyvrio Will Be Taken Off the Market, Its Maker Says
Results of a large clinical trial found the treatment did not work any better than a placebo. (Source: NYT Health)
Source: NYT Health - April 4, 2024 Category: Consumer Health News Authors: Pam Belluck Tags: Clinical Trials Drugs (Pharmaceuticals) Amyotrophic Lateral Sclerosis Suits and Litigation (Civil) Brain your-feed-science your-feed-healthcare Food and Drug Administration Source Type: news

FDA Approves Iloperidone for Bipolar Disorder FDA Approves Iloperidone for Bipolar Disorder
The US Food and Drug Administration has approved iloperidone tablets (Fanapt) for the treatment of bipolar disorder in adults.Medscape Medical News (Source: Medscape Psychiatry Headlines)
Source: Medscape Psychiatry Headlines - April 3, 2024 Category: Psychiatry Tags: Psychiatry Source Type: news

FDA Roundup: April 2, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Jazz Pharmaceuticals Completes Zanidatamab Biologics License Application for Previously Treated HER2-Positive Metastatic Biliary Tract Cancer
DUBLIN, April 2, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the company has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 2, 2024 Category: Drugs & Pharmacology Source Type: news

Some Doses Of Lilly's Mounjaro in Tight Supply Through April, US FDA Says Some Doses Of Lilly's Mounjaro in Tight Supply Through April, US FDA Says
Four doses of Eli Lilly ' s diabetes drug Mounjaro would remain in tight supply through 2024 due to soaring demand, the U.S. Food and Drug Administration ' s website...Reuters Health Information (Source: Medscape Diabetes Headlines)
Source: Medscape Diabetes Headlines - April 2, 2024 Category: Endocrinology Tags: Diabetes & Endocrinology Source Type: news

Voiant's Commitment to Quality Affirmed by FDA Inspection with No Findings Raised
Voiant, a leader in clinical trial imaging solutions, is proud to announce the successful completion of an inspection conducted by the U.S. Food and Drug Administration (FDA). WALTHAM, Mass., April 2, 2024 /PRNewswire-PRWeb/ -- Voiant, a leader in clinical trial imaging solutions, is... (Source: PRWeb: Medical Pharmaceuticals)
Source: PRWeb: Medical Pharmaceuticals - April 2, 2024 Category: Pharmaceuticals Tags: TRI Source Type: news

Vanda Pharmaceuticals' Fanapt (iloperidone) Receives U.S. FDA Approval for the Acute Treatment of Bipolar I Disorder
WASHINGTON, April 2, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 2, 2024 Category: Drugs & Pharmacology Source Type: news

FDA Approves Risvan (risperidone) for the Treatment of Schizophrenia
Madrid– 2 April, 2024– Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the“Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan®... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 2, 2024 Category: Drugs & Pharmacology Source Type: news