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Drug compounders sue FDA over semaglutide status

Hosted on MSN · 1h

Drug compounders sue over weight loss drugs’ removal from FDA shortage list

A trade group representing compounding pharmacies has filed a lawsuit against the Food and Drug Administration (FDA) for removing semaglutide, the active ingredient in Ozempic, from its drug shortage list.

Drug compounders sue US FDA over removal of Wegovy, Ozempic from shortage list

Drug compounders sued the U.S. Food and Drug Administration on Monday over its decision last week to remove Novo Nordisk's weight-loss and diabetes treatments Wegovy and Ozempic from its shortage list,

The National Law Review · 4h

GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List

On February 21, 2025, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order determining that the semaglutide drug shortage has been resolved. The timing of this order was unexpected due to the ongoing litigation between FDA and the Outsourcing Facilities Association (OFA) involving tirzepatide,

Medtronic gets FDA approval for Brainsense device

FDA approves first drug for rare lipid storage disease

An approval for the first drug for a rare lipid storage disease, some FDA workers rehired, and other biotech news of the day in the Readout newsletter.

US FDA approves Medtronic's medical device for Parkinson's disease

The U.S. Food and Drug Administration has approved Medtronic's deep brain stimulation system for use in patients with Parkinson's disease, the medical device maker said on Monday.

Business Insider · 1d

Medtronic’s BrainSense brain stimulation system approved by FDA for Parkinson’s

Medtronic (MDT) announced FDA approval of BrainSense Adaptive deep brain stimulation – aDBS – and BrainSense Electrode Identifier. There is no

Pfizer hires ex-FDA drug chief

The Hill on MSN · 1d

Pfizer hires ex-FDA drug chief as top doctor

The former head of the Food and Drug Administration’s (FDA) drug division is joining Pfizer as its chief medical officer, the company announced Monday. Patrizia Cavazzoni was formerly director of

Pfizer names former FDA director as chief medical officer

Pfizer on Monday named the former head of the U.S. health regulator's drug evaluation unit, Patrizia Cavazzoni, as its chief medical officer, bringing back an industry veteran to lead its regulatory and drug safety operations.

Barron's on MSN · 1d

Pfizer Hires Top FDA Official Just Weeks After She Leaves Agency

HHS secretary RFK Jr. said that he would “shut the revolving door to reestablish public trust” in the department.

First drug shown to reverse feline HCM expected to receive FDA conditional approval

Expanded conditional approval allows drugs that are undergoing their final clinical trial assessment and are supported by ...

1h

Teva, Medincell announce FDA acceptance of sNDA for Uzedy

Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries, and Medincell announced that the supplemental New Drug ...

Targeted Oncology2h

FDA Grants Perioperative Pembrolizumab Priority Review in HNSCC

The FDA granted priority review to pembrolizumab for neoadjuvant and adjuvant use in head and neck squamous cell carcinoma, ...

15h

Insight: Smokescreen: some vape firms pivot after FDA crackdown

Some e-cigarette companies targeted by U.S. authorities have altered their business model or changed their corporate ...

1don MSN

FDA moves to rehire medical device, food safety and other staffers fired days earlier

The reversal is the latest example of President Donald Trump and billionaire Elon Musk’s chaotic approach to cost-cutting, ...

1d

Frozen shakes served at nursing homes recalled after being linked to numerous deaths, hospitalizations: FDA

The FDA announced that a food distributor is recalling all ReadyCare and Sysco Imperial Frozen Supplemental shakes, typically ...

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