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FDA Grants Evoke Pharma with Market Exclusivity for GIMOTI®

David Kim04/26/2022

16820

Evoke Pharma, Inc. (NASDAQ: EVOK) has announced that the FDA has granted new drug product exclusivity for the company’s GIMOTI nasal spray. Evoke has been given exclusive marketing rights...

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FDA Authorizes Another Pfizer, Moderna Covid Booster for 50 and Up

Rebecca Urena03/29/202203/29/2022

17335

The Food and Drug Administration has authorized a fourth Covid vaccine dose for both Pfizer (NYSE: PFE) and Moderna (NASDAQ: PFE), for people 50 years of age and older....

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NeuroSense Therapeutics Achieves FDA Clearance of IND for PrimeC for Treatment of ALS

David Kim03/21/2022

20047

NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) has reported receipt of clearance from the United States Food and Drug Administration to begin a pharmacokinetic study of PrimeC in healthy adult subjects. ...

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Moderna Requests Emergency Use for Second Covid Booster Shot

Rebecca Urena03/18/202203/18/2022

17417

Moderna (NASDAQ: MRNA) announced Thursday that it is seeking the US Food and Drug Administration’s authorization for a second Covid-19 booster shot for people over the age of 18....

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Pfizer Receives FDA Approval for its Covid-19 Oral Treatment

Rebecca Urena12/22/2021

249

Pfizer’s (NYSE: PFE) oral Covid treatment, Paxlovid, was granted emergency authorization by the Food and Drug Administration on Wednesday. This is the first approved antiviral Covid-19 pill for infected...

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“The Buzz” Show: Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) Phase 3 Clinical Trial

financial buzz12/01/2021

2028

FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “Harmony Biosciences Holdings, Inc. is Set To Initiate Phase 3 Clinical Trial For Treatment Of Idiopathic Hypersomnia” Harmony...

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“The Buzz” Show: Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) FDA Approval for Caldolor

financial buzz11/30/2021

1978

FinancialBuzz.com’s latest The Buzz Show: Featuring Our Corporate News Recap on “Cumberland Pharmaceuticals Inc. Receives FDA Approval to Expand Labeling for Caldolor to Include Pre-Operative Administration” Cumberland Pharmaceuticals Inc....

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Cumberland Pharmaceuticals Reports FDA Approval for Caldolor

Bryan Shin11/30/2021

2910

Cumberland Pharmaceutical Inc. (NASDAQ: CPIX) has announced that the U.S. Food and Drug Administration has approved expanded labeling for Caldolor, a formulation of ibuprofen, to include use in pre-operative...

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Gracell Biotechnologies Granted FDA Drug Destination to Treat Multiple Myeloma

Andy Liao11/22/2021

1871

Gracell Biotechnologies Inc. (NASDAQ: GRCL) has reported that the U.S. FDA has granted Orphan Drug Destination for GC012F, Gracell’s FasTCARE-enabled BCMA/CD19 dual targeting CAR-T cell therapy for treatment of...

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Longeveron’s Lomecel-B Approved by FDA for Rare Pediatric Disease Designation

Andy Liao11/18/2021

3170

Longeveron Inc. (NASDAQ: LGVN) has received approval for Rare Pediatric Disease Designation for Lomecel-B by the FDA to treat Hypoplastic Left Heart Syndrom. HLHS is a rare life-threatening congenital...

Tag: FDA

FDA Grants Evoke Pharma with Market Exclusivity for GIMOTI®

FDA Authorizes Another Pfizer, Moderna Covid Booster for 50 and Up

NeuroSense Therapeutics Achieves FDA Clearance of IND for PrimeC for Treatment of ALS

Moderna Requests Emergency Use for Second Covid Booster Shot

Pfizer Receives FDA Approval for its Covid-19 Oral Treatment

“The Buzz” Show: Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY) Phase 3 Clinical Trial

“The Buzz” Show: Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX) FDA Approval for Caldolor

Cumberland Pharmaceuticals Reports FDA Approval for Caldolor

Gracell Biotechnologies Granted FDA Drug Destination to Treat Multiple Myeloma

Longeveron’s Lomecel-B Approved by FDA for Rare Pediatric Disease Designation

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