FDA

Conformis Inc

Conformis (NASDAQ: CFMS) Gets Green Signal for Identity Imprint Knee Replacement System

Shares of Conformis, Inc. (NASDAQ: CFMS) skyrocketed 7.23% during the trading session of Monday. The firm disclosed that it has got the green signal from the U.S. FDA for the firm’s Identity Imprint Knee Replacement System.

Motus GI Holdings Inc

Motus GI (NASDAQ: MOTS) Receives FDA’s Green Signal to Market Pure-Vu System

Motus GI Holdings, Inc. (NASDAQ: MOTS) declared that FDA has provided the green signal to the firm for the marketing of the Pure-Vu System.

Uber Technologies Inc

Uber (NYSE: UBER) Join Hands with empowerDX

Uber Technologies, Inc. (NYSE: UBER) and empowerDX disclosed Monday that they have joined hands to deliver FDA-emergency use authorized, at-home COVID-19 testing kits to consumers via on-demand delivery.

Gilead Sciences

Gilead (NASDAQ: GILD) Gets Approval for Trodelvy in Urothelial Cancer

Gilead Sciences Inc. (NASDAQ: GILD) disclosed that it has got the authorization from FDA for Trodelvy (sacituzumab govitecan-hziy) for use in grownup sufferers with locally developed or metastatic urothelial cancer (UC).

Sorrento Therapeutics Inc

Sorrento’s (NASDAQ: SRNE) Subsidiary Scilex Gets an sNDA Approval for ZTlido

Sorrento Therapeutics, Inc. (NASDAQ: SRNE) disclosed that Scilex Holding has got a supplemental new drug application (sNDA) authorization from the FDA for ZTlido. Scilex is the 99% owned unit of Sorrento Therapeutics.

AbbVie Inc

AbbVie (NYSE: ABBV) Announces FDA Extended Review Period for Upadacitinib’s NDA

AbbVie Inc. (NYSE: ABBV) declared that FDA has made the decision regarding the supplemental New Drug Application (sNDA) for upadacitinib. FDA has decided that it will extend the review period for sNDA for upadacitinib.

Bristol-Myers Squibb Company (BMY)

FDA Approves Bristol Myers (NYSE: BMY) Mavacamten NDA for Review

Bristol-Myers Squibb Company (NYSE: BMY) disclosed Friday that FDA has acknowledged the New Drug Application (NDA) of Mavacamten. FDA has decided to review the NDA of Mavacamten which is an investigational drug for the cure of the cardiac condition.

Regeneron Pharmaceuticals Inc

Regeneron (NASDAQ: REGN) And Sanofi’s Dupixent Accepted For Review By FDA

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NASDAQ: SNY) revealed on Thursday that FDA has awarded the authorization to Dupixent as an add-on cure for moderate-to-severe asthma.

AstraZeneca PLC

AstraZeneca (NASDAQ: AZN) Dump 7.7% Stake In Moderna Inc (NASDAQ: MRNA)

AstraZeneca Plc (NASDAQ: AZN) disclosed that it has dumped 7.7% stakes in US biotechnology firm Moderna Inc. AZN has dumped the holdings of Moderna Inc (NASDAQ: MRNA) for more than $1 billion.

Biofrontera AG

Why Biofrontera (NASDAQ: BFRA) Stock Is Crashing Today?

BFRA has declared the pricing of a U.S. underwritten public offering of 1,334,002 ADS at an offering price of $6.68 per ADS. Each ADS denotes two of BFRA’s ordinary shares, a minimal value of €1.00 per share.

Celsion Corporation

Celsion Corporation (NASDAQ: CLSN) Gets FDA Fast Track Designation for GEN-1

Celsion Corporation (NASDAQ: CLSN) has disclosed that US FDA has granted the firm’s GEN-1 Fast Track Designation.

Dr. Reddy's Laboratories Limited

Dr. Reddy’s (NYSE: RDY) Introduces Fluphenazine Hydrochloride Tablets

Dr. Reddy’s Laboratories Limited (NYSE: RDY) has introduced the Fluphenazine Hydrochloride Tablets, USP is US markets. The tablets are authorized by FDA.

Pfizer Inc. (PFE)

Pfizer-BioNTech To Deliver Additional 200M Doses Of COMIRNATY

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) revealed that the firms have signed an agreement with the European Commission (EC). As per the deal, the firms will deliver additional 200 million doses of COMIRNATY

Aurinia Pharmaceuticals Inc (AUPH)

Aurinia Pharmaceuticals (NASDAQ: AUPH) Receive FDA Approval For LUPKYNIS

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) disclosed that it has received the FDA authorization for LUPKYNIS™ (voclosporin). To treat Lupus Nephritis, LUPKYNIS is the first oral therapy that has got the endorsement of the FDA to treat adult sufferers with active lupus nephritis.

Adamis Pharmaceuticals Corporation (ADMP)

Adamis Pharmaceuticals (NASDAQ: ADMP) Submitted IND To FDA For Tempol

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has disclosed that it has submitted the Investigational New Drug (IND) application to FDA for Tempol. The purpose of this IND is to get authorization for the use of Tempol to cure the COVID-19 patients.

Neovasc Inc (NVCN)

Neovasc (NASDAQ: NVCN) Announces FDA Rejection Of Neovasc Reducer

Neovasc Inc. (NASDAQ: NVCN) disclosed that the FDA has rejected the Pre-Market Approval regarding its Neovasc Reducer™. FDA has assessed the Reducer for the treatment of patients with refractory angina pectoris.

$TNXP

Tonix Pharmaceuticals (NASDAQ: TNXP) Reports Encouraging Results In TNX-102 Study

Tonix Pharmaceutical Holding Corp. (NASDAQ: TNXP) has disclosed the positive results in the Phase III RELIEF study evaluating TNX-102 SL in fibromyalgia. RELIEF was 14 weeks study in which 503 victims with fibromyalgia were enrolled. In the first two weeks, all the victims have

$RNLX

FDA Grants Emergency Use Authorization To Kantaro's COVID-SeroKlir Test Kit

Renalytix AI Plc (NASDAQ: RNLX) and Mount Sinai Health System’s joint venture, Kantaro Biosciences, LLC, has been granted a EUA from the FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit. It is different from other test kits because it can

$STIM

FDA Approves Neuronetics’ (NASDAQ: STIM )TouchStar Technology

Neuronetics Inc. (NASDAQ: STIM), a technology firm focused on developing products to enhance the quality of life for patients suffering from mental ailments, recently declared that the FDA has permitted it to start using TouchStar treatment, an intermittent theta-burst (iTBS) protocol with its NeuroStar

(NASDAQ: ARGX)

Argenx SE (NASDAQ: ARGX) Inks Deal To Buy Priority Review Voucher

Argenx SE (NASDAQ: ARGX) has disclosed Monday that it has entered into an agreement to buy FDA Priority Review Voucher (PRV) from Bayer Healthcare Pharmaceuticals, Inc. for $98 million. This voucher enables its holder to an FDA priority review of A Biologics License Application

$AZN

AstraZeneca' (NASDAQ: AZN) Imfinzi Gets Green Signal In US

AstraZeneca PLC (NASDAQ: AZN) disclosed today that its Imfinzi has received approval for a new dosing option in the US for the treatment of small-cell lung cancer. FDA has granted this option after reviewing the various Imfinzi trials including the CASPIAN Phase III trial

Breaking News

Sanofi’ (NASDAQ: SNY) Rilzabrutinib Receives Fast Track Designation From FDA

Sanofi (NASDAQ: SNY) has declared today that its BTK inhibitor, Rilzabrutinib, has been awarded Fast Track Designation from FDA. Rilzabrutinib has shown encouraging results in the Phase ½ study and now it is planning to commence Phase III study. Rilzabrutinib has the potential to treat

Adamis Pharmaceuticals Corporation (ADMP)

FDA Rejects NDA For Adamis' (NASDAQ: ADMP) ZIMHI

Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) has announced Monday that it has got a Complete Response Letter (CRL) from FDA. The company disclosed that in CRL FDA declared that they need resubmission of NDA as the current application is not as per their priorities. Adamis

BioNTech SE (BNTX)

Pfizer And BioNTech COVID19 Vaccine Candidate Achieve 90% Success In Phase III Study

Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) have revealed today that the COVID-19 vaccine candidate, BNT162b2, has shown encouraging results in the first interim analysis from the Phase III study. The independent Data Monitoring Committee (DMC) has reviewed the mRNA-based vaccine candidate