FDA Archives - Page 66 of 220

2 minute read

Takeda And HUTCHMED Announce New Drug Application For Fruquintinib For Treatment Of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

May 25, 4:32 PM

− Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 30, 2023 − NDA Includes Results From the Phase 3 FRESCO-2 and FRESCO Clinical Trials Takeda ((TAK) and HUTCHMED (China)

HCM

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MindMed Calls FDA Experts To Validate LSD Drug Development Strategy

By Lara Goldstein

May 25, 2:52 PM

In a new chapter of the management quarrel between MindMed (NASDAQ: MNMD) executives and shareholder group FCM Holdings, t

MNMD

1 minute read

FDA Nods to Pfizer’s Paxlovid for COVID-19: A Potential $8 Billion Lifesaver in 2023

By Vandana Singh

May 25, 1:02 PM

The FDA has approved Pfizer Inc’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) for mild-to-moderate COVID-19 in adults who are at high…

PFE

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Lahey Hospital & Medical Center Agrees To Become One Of The U.S. Sites For The LIBERTY Robotic System’s First Human Trial

By Happy Mohamed

May 25, 8:44 AM

This Significant Achievement Represents Major Progression Toward Regulatory and Commercialization Paths Additional Sites in the U.S. Are Expected to Participate in the Trial HINGHAM, Mass., May 25, 2023

MBOT

4 minute read

MindMed Publishes Report By Leading FDA Experts Validating MindMed’s MM-120 Drug Development Strategy

By Happy Mohamed

May 25, 8:15 AM

Independent Third-Party Firm, Led by Former Senior FDA Officials, Calls Phase 2b Trial "Well-designed" and "Essential" Report Further Demonstrates that FCM's Proposal to Skip Phase 2 for MM-120

MNMD

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Myriad Genetics Adds Folate Receptor Alpha To Precise Oncology Solutions Portfolio To Expand Treatment Options For Women Living With Ovarian Cancer

By Happy Mohamed

May 24, 4:13 PM

Biomarker offers another companion diagnostic option to establish eligibility for FDA-approved drug ELAHERE® SALT LAKE CITY, May 24, 2023 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader

MYGN

1 minute read

Phathom Pharmaceuticals Resubmits FDA Application For Acid Blocker, Raises $131M Via Equity

By Vandana Singh

May 24, 12:31 PM

PHAT

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AstraZeneca-Spin Off Entasis Secures FDA Approval For First Pathogen-Targeted Therapy Addressing Acinetobacter

By Vandana Singh

May 24, 11:49 AM

Innoviva Inc’s (NASDAQ:INVA) affiliate Entasis Therapeutics Inc received FDA approval for Xacduro (sulbactam and durlobactam for injection), co-packaged as a treatment…

AZN

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FDA Extends Review For Sarepta Therapeutics’ Duchenne Gene Therapy By Couple Of Weeks

By Vandana Singh

May 24, 10:28 AM

The FDA informed Sarepta Therapeutics Inc (NASDAQ:SRPT) that it requires modest additional time to complete the review of its SRP-9001…

SRPT

2 minute read

Option Care Health Selected By Krystal Biotech As Part Of A Limited Distribution Specialty Pharmacy Network For VYJUVEK

By Benzinga Newsdesk

May 23, 4:22 PM

Company to Deliver to Patients FDA-Approved Topical Treatment for Dystrophic Epidermolysis Bullosa (DEB)Announces Collaboration with Amedisys to Administer Treatment in the HomeBANNOCKBURN, Ill., May 23, 2023 (GLOBE

KRYS