FDA Newswatch Today's News
FDA Approves JEMPERLI (dostarlimab-gxly) for dMMR Endometrial Cancer
22 Apr 2021 20:13:03 UT
PD-1 Antagonist Antibody Under Clinical Development for Solid Tumors in Collaboration with GlaxoSmithKline (GSK) First AnaptysBio-Generated Antibody, of 8 Currently Under Clinical Development, to...
Buchanan announces bipartisan legislation to end FDA animal testing
22 Apr 2021 17:52:11 UT
SARASOTA, Fla. (WWSB) - Suncoast Congressman Vern Buchanan announced that he has introduced bipartisan legislation to end a government requirement that animal testing be used to determine a drug’s...
Istari Oncology, now with FDA clearance for PVSRIPO, raises $43.4M
22 Apr 2021 17:38:05 UT
DURHAM —  Istari Oncology  has raised $43.4 million from 17 investors, according to an SEC filing . Following the filing, the Durham-based clinical-stage biotechnology company received clearance...
Getinge wins 3 FDA clearances for ventilators
22 Apr 2021 15:56:53 UT
Getinge  announced today that it received FDA 510(k) clearance for three products to expand its Servo platform of ventilators. Gothenburg, Sweden-based Getinge’s latest clearances are for new...
US FDA Clears Apic Bio IND Application for Lead Gene Therapy Candidate APB-102 for the Treatment of SOD1 ALS
22 Apr 2021 12:00:00 UT
M2PHARMA-April 22, 2021-US FDA Clears Apic Bio IND Application for Lead Gene Therapy Candidate APB-102 for the Treatment of SOD1 ALS - The US Food and Drug Administration has cleared US-based rare...
Capricor Presents Positive Data from the DYNAMIC Clinical Trial; Collegium Announces FDA Tentative Approval for Xtampza(TM) ER
22 Apr 2021 17:19:20 UT
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 9, 2015.       Capricor Therapeutics, Inc. (NASDAQ: CAPR) , a biotechnology company...
FDA Approves Genentech’s Cotellic™ in Combination With Zelboraf®; FORUM Announces Removal of Partial Clinical Hold on Phase 3 Encenicline Program
22 Apr 2021 17:19:19 UT
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 11, 2015.    Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) ,...
MediciNova Receives Notice of Allowance for New Patent Covering MN-221; FDA Grants TEVA Therapy Designation for SD-809
22 Apr 2021 17:19:19 UT
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 10, 2015.      MediciNova, Inc.,  (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo...
A look ahead at the FDA meeting that could decide the future of 6 cancer drug approvals
22 Apr 2021 16:44:24 UT
Next week, a panel of advisers to the Food and Drug Administration will convene to debate the merits of six recent cancer immunotherapy approvals handed out by the agency. In each case, approval...
Public Citizen: FDA's Approval of COVID-19 Treatment Should Be Promptly Revisited in Consultation With Outside Experts
22 Apr 2021 13:34:18 UT
Public Citizen issued the following news release on April 21, 2021: The U.S. Food and Drug Administration (FDA) should promptly convene an external expert advisory panel to evaluate whether the...
FDA Gives vTv's TTP399 Breakthrough Designation
21 Apr 2021 19:29:22 UT
. High Point’s vTv Therapeutics Inc. has received the U.S. Food and Drug Administration designation as a Breakthrough Therapy for its TTP399 oral supplement treating type 1 diabetes and psoriasis. ...
FDA Approvals Roundup: Nextstellis, Ragwitek, Opdivo
21 Apr 2021 19:38:34 UT
A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Nextstellis cleared as first new oral contraceptive in over 50 years Mayne’s...
Agenus Submits Balstilimab Biologics License Application to the US FDA for Patients With Recurrent or Metastatic Cervical Cancer
21 Apr 2021 18:38:26 UT
Agenus Inc. recently announced the submission of a Biologics License Application (BLA) to the US FDA for the accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody, for the treatment of...
Key FDA Drug and Device Updates
21 Apr 2021 19:11:29 UT
Article By Over the past month, there have been a significant number of developments affecting FDA-regulated companies. This GT Alert provides an update on key FDA personnel...
LEXEO Therapeutics Announces FDA Fast-Track Designation
21 Apr 2021 18:01:38 UT
LEXEO Therapeutics recently announced the US FDA has granted Fast Track designation to LX1001, the company’s adeno-associated virus (AAV) mediated gene therapy program, for the potential treatment of...
HHS withdraws proposal to exempt 84 medical device types from FDA 510(k) process
21 Apr 2021 00:00:00 UT
On April 16, the U.S. Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) published a notice of withdrawal of their January 15 proposal to exempt 84 medical device...
FDA Approves Medtronic's Embolization Device For Stopping Brain Aneurysms
21 Apr 2021 16:41:09 UT
The  FDA has approved   Medtronic plc’s  (NYSE:  MDT ) Pipeline Flex Embolization Device with Shield Technology, a chemically bonded, synthetic coating that helps camouflage the metal implant from...
FDA Guidance Document Concerning Use of Pilot Manufacturing Facilities for the Development and Manufacture of Biological Products; Availability
21 Apr 2021 15:11:45 UT
Docket Number: 95D–0164 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research The Food and Drug Administration (FDA) is announcing the availability of a...
LivaNova Receives FDA 510(k) Clearance for Blood-Gas Monitoring System
21 Apr 2021 14:54:12 UT
London-based LivaNova PLC announces that it has received U.S. FDA 510(k) clearance for B-Capta, the in-line, blood-gas monitoring system integrated into the S5 heart-lung machine (HLM). The system...
Medtronic receives U.S. FDA approval for Pipeline Flex Embolization Device with Shield Technology
21 Apr 2021 13:56:34 UT
April 21, 2021  –  Medtronic plc (Dublin, Ireland) announced it has received approval from the United States Food and Drug Administration (FDA) for Pipeline Flex Embolization Device with Shield...

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