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Sanofi, Regeneron and FDA

Sanofi-Regeneron's Dupixent wins FDA's nod for 'smoker's lung'

The U.S. Food and Drug Administration has approved Sanofi and Regeneron's blockbuster drug Dupixent for patients with a chronic lung disease, commonly known as "smoker's lung", the companies said on Friday.

Investopedia · 15m

Regeneron-Sanofi Drug Wins FDA Approval To Treat COPD

Shares of Regeneron Pharmaceuticals and Sanofi edged higher Friday after their drug to treat chronic obstructive pulmonary disease received approval from the Food and Drug Administration.

Business Insider · 6h

Regeneron, Sanofi's Dupixent Get FDA Approval For Chronic Obstructive Pulmonary Disease Treatment

Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi (SNY), Friday announced that the U.S. Food and Drug Administration has approved

The Wall Street Journal on MSN · 6h

Regeneron, Sanofi Get FDA OK for Dupixent to Treat COPD

Regeneron Pharmaceuticals and Sanofi have won FDA expanded approval of their blockbuster anti-inflammatory drug Dupixent in chronic obstructive pulmonary disease.

AOL · 7h

US FDA approves Sanofi-Regeneron's Dupixent for 'smoker's lung'

Sanofi recorded 10.72 billion euros ($11.94 billion) in sales for Dupixent in 2023, which includes Regeneron's share. Analysts on average expect Dupixent, by far Sanofi's best-selling drug, to generate more than 21 billion euros in sales in 2030,

FDA Approves 1st New Schizophrenia Drug in Decades

Everyday Health · 20m

FDA Approves the First New Type of Schizophrenia Drug in Decades

Cobenfy doesn’t have the same severe side effects as older schizophrenia medications — like weight gain, involuntary muscle movement, and sedation — that can cause patients to discontinue treatment.

Gizmodo · 1h

FDA Approves Potentially Groundbreaking Schizophrenia Drug

On Thursday, the Food and Drug Administration approved Cobenfy, a drug from Bristol Myers Squibb—the first truly novel treatment for schizophrenia in decades.

U.S. News & World Report · 10h

FDA Approves New Kind of Drug for Schizophrenia

FRIDAY, Sept. 27, 2024 (HealthDay News) -- The first new type of medication in decades to help fight against schizophrenia was approved on Thursday by the U.S. Food and Drug Administration.

breast implant, FDA and Motiva

GlobalData on MSN · 4h

FDA approves Establishment Labs’ Motiva breast implants

The Motiva implants feature the patented SmoothSilk surface, engineered to improve biocompatibility and minimise inflammation.

MarketWatch · 10h

Establishment Labs Shares Surge Premarket on FDA Breast Implant Approval

Establishment Labs Holdings shares jumped nearly 30% in premarket trading Friday after the medical-technology company won Food and Drug Administration approval for its Motiva breast implants. After the closing bell Thursday,

Business Insider · 15h

Buy Rating Affirmed: Establishment Labs’ Motiva Implant Poised to Disrupt the US Breast Implant Market

Josh Jennings, an analyst from TD Cowen, reiterated the Buy rating on Establishment Labs Holdings (ESTA – Research Report). The

FDA Lifts Clinical Hold on BMF-219

Reuters on MSN · 22h

US FDA lifts clinical hold on Biomea's diabetes trials after safety review

The U.S. Food and Drug Administration lifted a clinical hold on Biomea Fusion's ongoing studies of its experimental drug for type 1 and type 2 diabetes, the drug developer said on Thursday. The regulator had placed a hold on two trials of its lead drug,

Business Insider · 17h

Biomea Fusion : FDA Lifts Clinical Hold On BMF-219 For Type 1 And Type 2 Diabetes Trials; Stock Up

Biomea Fusion Inc. (BMEA) announced that the U.S. Food and Drug Administration has lifted the clinical hold on the company's ongoing

MarketWatch · 1d

Biomea Fusion: FDA Lifts Hold on Diabetes-Treatment Trials

Biomea Fusion said the Food and Drug Administration lifted its clinical hold on continuing clinical trials of the company's diabetes drug. The FDA in June put the biopharmaceutical company's trials on hold,

56mon MSNOpinion

Column: A federal appeals court hands the FDA a stupendous win in its battle against stem cell clinics

Just as it began to seem that the battle against pseudoscience in medicine was being lost, a federal appeals court in San ...

STAT48m

The FDA is ‘making sandwiches,’ ‘breakfast salad’ in DC, and what keeps us from choking on food

Get your daily dose of health and medicine every weekday with STAT’s free newsletter Morning Rounds. Sign up here. In a new ...

Targeted Oncology14m

FDA Grants Traditional Approval to Selpercatinib in RET+ Medullary Cancer

The FDA granted traditional approval to selpercatinib for the treatment of advanced or metastatic RET-mutated medullary ...

WGBH1h

The FDA approved an at-home nasal spray flu vaccine, but it's not available quite yet

A nasal spray to prevent influenza could make it easier for more people to get vaccinated, said Dr. Katherine Gergen-Barnett.

28m

EQS-Adhoc: FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz)

FDA grants approval for Stelara® Biosimilar FYB202/OtulfiTM (ustekinumab-aauz) Planegg-Martinsried, Germany, September 27, 2024 – Formycon AG (FSE: FYB, "Formycon“) announces that the U.S. Food and ...

20h

FDA approves new schizophrenia drug

The U.S. Food and Drug Administration has approved a new drug for adults with schizophrenia, the FDA announced Thursday.

JD Supra2h

FDA Issues Multiple Guidances Supporting Clinical Trial Innovation

In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical ...

MedPage Today5h

COVID Preventive Drug Should Work Against Circulating Variants, FDA Now Says

The FDA has determined that the monoclonal antibody pemivibart (Pemgarda) is likely to be effective against currently ...

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