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The Latest Breaking News from FDA

Atara Biotherapeutics Shares Fall After Reporting Patient Death In ATA2271 Autologous CAR T Trial

Memorial Sloan Kettering Cancer Center's (MSK) has notified the FDA of a fatal serious adverse event (SAE) associated with a patien

Benzinga

FDA Asks For More Data To Resolve BioMarin's Gene Therapy Clinical Hold

BioMarin Pharmaceutical Inc (NASDAQ: BMRN) said that the

Benzinga

Baby formula recalled over bacteria fears after baby dies

FDA says four children were hospitalised with illness, and one of them later died

The Independent UK

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The Daily Biotech Pulse: Regeneron-Sanofi Halt Late-Stage Dupixent Study, Agios Gets FDA Nod, Safety Scare For GSK's RSV Vaccine, Shockwave Jumps On Earnings

Here's a roundup of top developments in the biotech space over the last 24 hours.

Benzinga

FDA Approves Agios' Mitapivat As First Disease-Modifying Therapy For Genetic Blood Disorder

The

Benzinga

FDA says official suggesting annual COVID vaccines ‘does not work on vaccine matters’

A video has emerged of a Food and Drug Administration executive suggesting there are plans for annual COVID-19 vaccines to be implemented in the United States.

McClatchy Washington Bureau

Parents spark breakthrough gene therapy for devastating child disease ignored by big pharma

Exclusive: For more than a century there has been no cure, no treatment and no hope for children diagnosed with Tay-Sachs disease. Now grassroots campaigns to fund research are on the brink of delivering a breakthrough, Io Dodds reports

The Independent UK

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Apyx Medical Submits Additional FDA 510(k) For Expanded Use Of Renuvion In Dermatological Procedures

Apyx Medical Corporation (NASDAQ: APYX) announced the publication of an article in a journal featuring the results of its U.S. IDE study evaluating the Renuvion Dermal Handpiece using Apyx's Helium Plasma Technology for dermal resurfacing procedures.

Benzinga

FDA Sets Up Adcomm To Review Amylyx's ALS Drug Next Month

The FDA's Peripheral and Central Nervous System Drugs Advisory Committee will review Amylyx Pharmaceuticals Inc's (NASDAQ: AMLX) marketing application for AMX0035 (sodium phenylbutyrate [PB] and taurursodiol)

Benzinga

The Daily Biotech Pulse: J&J Unit Announces Research Collaboration With Remix, Regencell Touts COVID Data, Decision Day For Agios

Here's a roundup of top developments in the biotech space over the last 24 hours: Stocks In Focus Amylyx's ALS Treatment Regulatory Application To Be Reviewed By FDA Panel In Late March

Benzinga

Inside the tactical tug of war over the controversial Alzheimer’s drug

The drug industry, patient advocates and congressional Republicans have all attacked federal officials’ decision to decline routine Medicare coverage for a controversial Alzheimer’s drug. They’ve gone as far as to accuse them of tacit racism, ageism and discrimination against the disabled — and hinted at a lawsuit — over the…

Tribune News Service

Outset Medical More Than Doubles Sales In FY21, Issues Better Than Expected FY22 Outlook

Outset Medical Inc (NASDAQ:OM) recorded Q4 FY21 net revenue of $28.2 million, a 63.2%, beating the consensus of $26.42 million. Product revenue for the fourth quarter of 2021 was $23.7 million, +79.5%. The Company achieved a gross margin of 11.8%, compared to 2.4% in the fourth quarter of 2020 Select Development: The…

Benzinga

ATE.TO: First Human PK/PD Studies Underway in Otenaproxesul's Post-Operative Pain Program…

By David Bautz, PhD OTC:ATBPF | TSX:ATE.TO READ THE FULL ATE.TO RESEARCH REPORT

Benzinga

US Senate Narrowly Votes In Favor Of Biden's Nominee Robert Califf To Lead FDA For Second Time

By a narrow vote of 50-46, the Senate has confirmed Robert Califf to run the FDA.

Benzinga

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Benzinga

Mirati Therapeutics' Adagrasib Application Under FDA Review For Lung Cancer Setting

The

Benzinga

FDA's AdComm Says Avenue Therapeutics Submitted Insufficient Data On IV Tramadol

Avenue Therapeutics Inc (NASDAQ: ATXI) announced the outcome of the FDA meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on IV tramadol.

Tribune News Service

Patients’ groups, progressives square off over Medicare Alzheimer’s decision

WASHINGTON — Advocates on both sides of a debate over dramatically restricting Medicare’s coverage of an expensive and controversial Alzheimer’s treatment are waging competing campaigns to influence a final decision in April.

Tribune News Service

Senate confirms Robert Califf to become Biden’s FDA commissioner

WASHINGTON — The Senate on Tuesday confirmed Robert Califf to lead the Food and Drug Administration, 50-46, a much narrower vote than when he previously held the position during the Obama administration, though many thought the latest vote could be even closer.

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news in one place.

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Axios

Senate confirms Robert Califf as FDA commissioner

The agency has been without a permanent leader for more than a year.

The Independent UK

Senate confirms Biden's FDA pick despite political divisions

The Senate has narrowly confirmed President Joe Biden’s pick to lead the Food and Drug Administration, filling a position that had been open for more than a year

StockNews.com

Is Senseonics Holdings a Smart Investment in 2022?

The shares of medical technology stock Senseonics Holdings (SENS) dipped marginally in price yesterday, despite the company receiving FDA approval for its Eversense E3 glucose monitoring system. So, with unsustainable valuations and a bleak earnings outlook, will SENS'stock be able to regain forward momentum soon? Read more to learn our…

Benzinga

FDA Signs Off Citius Pharma's Phase 2 Trial With Halo-Lido In Hemorrhoids

The

Roll Call

Patients' groups, progressives square off over Medicare Alzheimer's decision - Roll Call

Competing campaigns look to influence the debate over dramatically restricting coverage of a controversial treatment drug Aduhelm.

Roll Call

Senate confirms Califf to become Biden's FDA commissioner - Roll Call

Six Republicans voted Tuesday to confirm FDA nominee Robert Califf, who had seen opposition from pockets of the Democratic caucus.

Benzinga

FDA Slams Brakes On Legend Biotech's CAR-T Therapy Trial In Lymphoma Patients

The FDA has instituted a clinical hold on Legend Biotech Corporation's (NASDAQ:

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