FDA Archives - Page 38 of 220

1 minute read

Regulatory Hurdle For Innate Pharma’s Blood Cancer Studies

October 5, 8:19 AM

The FDA has placed a clinical hold on Innate Pharma SA's (NASDAQ: IPHA) lacutamab Investigational New Drug (IND), leading to a pause in new patient enrollment in ongoing lacutamab trials IPH4102-201 (Phase 2 TELLOMAK) and 102 (Phase 1b PTCL).

IPHA

1 minute read

Novavax’s COVID-19 Shot Just In Time, Optimism Surrounds As Demand Picks Up Momentum

By Vandana Singh

October 4, 3:19 PM

Tuesday, the FDA granted an emergency use nod to Novavax Inc's (NASDAQ: NVAX) COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) for active immunization to prevent COVID-19 in

NVAX

2 minute read

Is Amgen’s Lung Cancer Drug Lumakras Up to the Mark? FDA Briefing Raises Concerns

By Vandana Singh

October 3, 3:30 PM

The FDA released briefing documents ahead of Oncologic Drugs Advisory Committee meeting scheduled for October 5 to review Amgen Inc's (NASDAQ:

AMGN

1 minute read

Novavax Stock Soars On FDA Clearance For Updated Covid-19 Shot: What’s Going On?

By Adam Eckert

October 3, 3:17 PM

Novavax Inc (NASDAQ: NVAX) shares are surging Tuesday afternoon after the U.S.

BNTX

1 minute read

Takeda Withdraws Lung Cancer Drug From US After Failed Confirmatory Trial

By Vandana Singh

October 3, 8:38 AM

Following discussions with the FDA, Takeda Pharmaceutical Co Ltd (NYSE: TAK) will voluntarily withdraw Exkivity (mobocertinib)

TAK

2 minute read

GH Research’s Psychedelic Drug Candidate For Depression Meets FDA: Clinical Program On Hold

By Lara Goldstein

October 2, 5:56 PM

After the usual 30-day review period, the Food and Drug Administration (FDA) placed GH Research’s (NASDAQ: GHRS) Investigational New Drug (IND) application for a Phase 1 clinical trial of proprietary inhalable 5-MeO-DMT compound GH001 on clinical hold due to “insufficient information to assess risks on huma

GHRS

1 minute read

FDA Declines To Approve Eli Lilly’s Eczema Drug

By Vandana Singh

October 2, 11:46 AM

The U.S.

LLY

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Why Is Genetic Testing Invitae Stock Trading Higher Today?

By Vandana Singh

October 2, 11:37 AM

Friday, the FDA granted de novo approval for Invitae Corporation's (NYSE:

NVTA

3 minute read

FDA Approves Rivfloza For Children ≥9 Years Old And Adults Living With Primary Hyperoxaluria Type 1 (PH1), A Rare Genetic Condition

By Benzinga Newsdesk

October 2, 11:16 AM

Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved RivflozaTM (nedosiran) injection 80 mg, 128 mg, or 160 mg, a once-monthly subcutaneous ribonucleic acid interference (RNAi)

NVO

3 minute read

Reported September 29. ‘FDA Grants First Marketing Authorization For A DNA Test To Assess Predisposition For Dozens Of Cancer Types’

By Benzinga Newsdesk

October 2, 9:43 AM

https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-typesToday, the U.S. Food and Drug Administration granted de novo marketing

NVTA