Replimune stock soars on FDA priority review for melanoma treatment
Shares of Replimune Group, Inc. (NASDAQ: NASDAQ:REPL) surged 17% following the announcement that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1,
Sanofi says FDA lifted clinical hold on trial for Cialis OTC switch
Sanofi’s (NASDAQ:SNY) consumer healthcare unit Opella announced Tuesday that the U.S. FDA has lifted a clinical hold on a trial designed to test an over-the-counter version of its erectile dysfunction (ED) drug,

FDA, Atara

Atara extends losses after FDA clinical hold
Atara Biotherapeutics Faces Uncertainty Amid FDA Clinical Hold and Financing Needs, Resulting in Hold Rating
Atara Biotherapeutics (ATRA – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Benjamin
US FDA puts clinical hold on Atara's trials for cancer cell therapies
FDA lifts clinical hold on Amylyx ALS drug study
Shares of Amylyx Pharmaceuticals (NASDAQ:AMLX) fell 13% in morning trading Tuesday amid news that an FDA clinical hold on a Phase 1 study for its ALS drug candidate AMX0114 has been lifted. Amylyx (NASDAQ:AMLX) said it is now working to open U.
FDA accepts Replimune's advanced melanoma therapy BLA
Replimune Group Inc (NASDAQ: NASDAQ:REPL), a biotech firm focused on oncolytic immunotherapies, announced today that its Biologics License Application (BLA) for RP1 in combination with nivolumab has been accepted by the U.
Nasdaq5d
ImmunityBio Provides Update On FDA Submissions For 2025
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq4d
FDA Okays AstraZeneca And Daiichi's Datroway For Metastatic HR-Positive, HER2-Negative Breast Cancer
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s by Andrew Mariathasan in New York ...
Nasdaq7d
FDA Reduced Nicotine Proposal Could Benefit 13 Mln Smokers, Highlights 22nd Century's VLN Cigarettes
VLN cigarettes are the first and only combustible tobacco products authorized by the FDA under its Modified Risk ... do not necessarily reflect those of Nasdaq, Inc. Founded in the late 1990s ...
Nasdaq11d
FDA Accepts J&J's Filing for Autoimmune Disease Drug Nipocalimab
Johnson & Johnson JNJ announced that the FDA has accepted its regulatory filing seeking the FDA’s approval for nipocalimab, its investigational neonatal Fc receptor (FcRn) blocker, in ...
CERO Therapeutics secures NASDAQ compliance extension
CERO Therapeutics Holdings, Inc. (NASDAQ:CERO), currently trading at $2.34 with a market capitalization of $4.49 million, has been granted an extension until April 22, 2025, to meet NASDAQ's continued listing requirements.
Nasdaq5d
FDA Approves LUMAKRAS With Vectibix For KRAS G12C-Mutated MCRC
(RTTNews) - Amgen, Inc. (AMGN) a biopharmaceutical company on Friday, announced that the FDA has approved LUMAKRAS or sotorasib in combination with Vectibix or panitumumab for the treatment of ...
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation