FDA Archives - Page 183 of 220

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Erasca Presents Preliminary Phase 1/1b Monotherapy Data For ERAS-007 ERK And ERAS-601 SHP2 Inhibitors Supporting Ongoing And Future Combination Trials

September 7, 4:14 PM

23% (6/26) of patients with RAS/MAPK-altered non-CRC solid tumors and 44% (4/9) with BRAF-driven non-CRC solid tumors responded (confirmed and unconfirmed PR) to single agent ERAS-007 or

ERAS

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FDA
News

Veru Announces Oct. 6 Date For FDA Advisory Committee Meeting To Review Emergency Use Authorization For Sabizabulin For Hospitalized COVID-19 Patients At High Risk For Acute Respiratory Distress Syndrome

By Bill Haddad

September 7, 1:46 PM

MIAMI, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ:VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral and ARDS-related diseases and for the management of breast

VERU

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Inspiratm Technologies Performed Hylatm Blood Sensor In-Vivo Study, In Preparation Of Planned Human Studies

By Benzinga Newsdesk

September 7, 9:34 AM

- Reuters

IINN

3 minute read

E-Cigarette Maker To Pay Over $430M To Settle Multi-State Vaping Inquiry, Cannabis Investors Need To Pay Attention

By Jelena Martinovic

September 7, 9:32 AM

E-cigarette producer Juul Labs agreed to pay $438.5 million to 34 states and territories to sort out a two-year bipartisan investigation into its marketing and sales practices.

CGC

8 minute read

Cel-Sci Corporation Issues Letter to Shareholders; Multikine Reduced And Eliminated Tumors Within 3 Weeks; Nearly 4-Year Median Overall Survival Benefit In The Radiation-Only Group; Data Presentations At ASCO And ESMO

By Benzinga Newsdesk

September 7, 8:52 AM

Multikine® reduced and eliminated tumors within 3 weeks and before surgery Nearly 4-year median overall survival benefit in the radiation-only group Data presentations at ASCO and ESMO world-leading peer review

CVM

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Pfizer Gets FDA Breakthrough Therapy Designation For GBS Vaccine Candidate

By Ragothaman Srinivasan

September 7, 8:17 AM

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Pfizer’s (NYSE: PFE) lead drug GBS6 or PF-06760805 for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.

PFE

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Praxis Precision Medicines Announces Plan To Start PRAX-222 EMBRAVE Clinical Study

By Bill Haddad

September 7, 7:34 AM

BOSTON, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ:PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central

PRAX

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Philips Recalls Some Masks Used With Respiratory Devices Over Potential Injury Risk

By Vandana Singh

September 7, 6:58 AM

The FDA said Koninklijke Philips NV (NYSE:PHG) recalled certain masks used with some of its respiratory machines due to the potential risk…

PHG

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Eledon Shares Climb After Securing FDA Nod For Mid-Stage Kidney Disease Study

By Ragothaman Srinivasan

September 6, 4:27 PM

Eledon Pharmaceuticals (NASDAQ: ELDN) received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to evaluate tegoprubart for the treatment of IgA Nephropathy (IgAN).

ELDN

2 minute read

FDA Again Highlights Lacking Data From Amylyx’s Amyotrophic Lateral Sclerosis Candidate

By Vandana Singh

September 6, 3:12 PM

The FDA released briefing documents for Amylyx Pharmaceuticals Inc’s (NASDAQ:AMLX) experimental amyotrophic lateral sclerosis drug, as a second adcomm is scheduled…

AMLX