FDA Archives - Page 64 of 220

1 minute read

Breakthrough in CRISPR-Based Therapy: FDA Accepts Vertex and CRISPR Therapeutics’ Exa-cel Application

June 9, 2:08 PM

The FDA has accepted the application for Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics AG (NASDAQ: CRSP) exa-cel for sickle cell disease and transfusion-dependent

BLUE

1 minute read

Why Are Sientra Shares Surging Today

By Vandana Singh

June 9, 11:38 AM

Sientra Inc (NASDAQ: SIEN) shares are trading after the FDA granted a 510k-clearance to its

SIEN

3 minute read

‘FDA Advisors Weigh Whether Alzheimer’s Drug Leqembi Should Receive Full Approval, Will Make A Final Decision On July 6’ – CNBC

By Happy Mohamed

June 9, 11:10 AM

https://www.cnbc.com/2023/06/09/fda-advisors-review-alzheimers-drug-leqembi-for-full-approval.html The FDA’s independent advisors will make a recommendation on whether Eisai and Biogen’s Alzheimer’s

BIIB

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Unanimous Support for AstraZeneca and Sanofi’s Nirsevimab: Next Generation RSV Treatment on the Horizon

By Vandana Singh

June 9, 8:07 AM

The FDA's Antimicrobial Drugs Advisory Committee has voted unanimously 21 to 0 that AstraZeneca plc (NASDAQ: AZN) and Sanofi SA's (NASDAQ: SNY) nirsevimab has a favorable benefit-risk profile t

AZN

1 minute read

FDA Readies Proposal for Increased Oversight on Lab-developed Tests

By Vandana Singh

June 8, 2:00 PM

The FDA is preparing to increase regulation of a widely used class of tests conducted by laboratories to detect cancer, measure cholesterol, and identify other health issues. The FDA is developing a proposal to ensure these tests' effectiveness and accuracy.

DGX

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FDA Signals Support for Eisai-Biogen Alzheimer’s Drug Data Confirms Benefits For Complete Approval

By Vandana Singh

June 8, 8:34 AM

FDA Peripheral and Central Drugs Advisory Committee is meeting Friday (June 9) to discuss a supplemental marketing application for Leqembi (lecanemab) submitted by Eisai Co Ltd (OTC: ESALY) for Alzheimer's disease, initiated in patients with mild cognitive impairment or mild dementia stage of th

BIIB

2 minute read

Capricor Therapeutics Announces Follow-Up Type-B Clinical Meeting With The FDA For CAP-1002 For The Treatment Of Duchenne Muscular Dystrophy

By Benzinga Newsdesk

June 7, 9:17 AM

Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases,

CAPR

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Cue Health Becomes First Company to Receive FDA De Novo Authorization COVID-19 Home Use Test

By Vandana Singh

June 7, 8:54 AM

Cue Health Inc (NASDAQ: HLTH) became the first company to receive De Novo authorization from the FDA for its Cue COVID-19 Molecular Test, designed for both home and

HLTH

1 minute read

FDA Prioritizes GSK’s Breakthrough Drug Jemperli for Endometrial Cancer Treatment, a First in Decades

By Vandana Singh

June 6, 9:36 AM

The FDA accepted the supplemental marketing application for GSK Plc’s (NYSE:GSK) Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with…

GSK

1 minute read

Why Are Timber Pharmaceuticals Shares Trading Higher Today

By Vandana Singh

June 5, 8:31 AM

The FDA has granted dermal carcinogenicity (CARC) waiver for Timber Pharmaceuticals Inc's (NYSE: TMBR) TMB-001, a topical isotretinoin formulated using the company's patented IPEG delivery system.

TMBR