Johnson & Johnson Reports Q2 2021 Results
New Brunswick, N.J. (July 21, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter. “Our second-quarter results showcase Johnson & Johnson’s diversified portfolio, driven by strong sales and earnings growth across our Medical Device, Consumer Health and Pharmaceutical businesses,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m so proud of our 136,000 colleagues who remain focused on delivering our medicines and products to patients and consumers around the world, in addition to advancing our pipeline with new product launches and regulato...
Source: Johnson and Johnson - July 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film
WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease
16 July 2021 -- The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

Alembic Pharma gets USFDA nod for cancer treatment drug
The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Erlotinib tablets in the strengths of 25 mg, 100 mg, and 150 mg, Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 9, 2021 Category: Pharmaceuticals Source Type: news

Clinical Data Summary Pilot Program
CDER has launched a pilot program to assess the feasibility of using a different format to provide required summaries of the safety and effectiveness information that is used to make regulatory decisions. The pilot program will include up to nine recently submitted new drug applications (NDAs). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Tezepelumab Granted Priority Review By U.S. FDA
THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 7, 2021 Category: Drugs & Pharmacology Source Type: news

Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals
RED BANK, N.J., July 6, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 6, 2021 Category: Drugs & Pharmacology Source Type: news

Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
Clinical Medicine (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 1, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis
BALTIMORE, July 1, 2021 /PRNewswire/ --Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting Capsid Inhibitor for the Treatment of HIV-1 in People With Limited Therapy Options
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 28, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the company completed submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 28, 2021 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Resubmits New Drug Application for Libervant (diazepam) Buccal Film
WARREN, N.J., June 24, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 24, 2021 Category: Drugs & Pharmacology Source Type: news

Janssen Submits New Drug Application to U.S. FDA for XARELTO ® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
RARITAN, NJ, June 23, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of XARELTO® (rivaroxaban) in pediatric patients. The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with co...
Source: Johnson and Johnson - June 23, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Cipla gets USFDA nod for inhalation product
The company has received final approval for its abbreviated new drug application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL from the United States Food and Drug Administration (US FDA), Cipla said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 23, 2021 Category: Pharmaceuticals Source Type: news

Fennec Pharmaceuticals Announces FDA Acceptance of New Drug Application Resubmission for Pedmark
Research Triangle Park, NC, June 22, 2021– Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the resubmission of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 22, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Soaanz (torsemide) for Edema Treatment in Patients with Heart Failure and Renal Disease
VIENNA, VA. (PRWEB) JUNE 21, 2021 Sarfez Pharmaceuticals announced today approval by the U.S. Food and Drug Administration (FDA) of the Virginia-based company’s New Drug Application for Soaanz, a once-a-day improved formulation of the loop... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

Braeburn resubmits new drug application for experimental opioid use disorder treatment
Montgomery County drug developer Braeburn Inc. has resubmitted its new drug application for Brixadi, the firm's experimental therapy for opioid use disorder. The resubmission is in response to the FDA's rejection of the new drug candidate in December. The FDA cited deficiencies found during an inspection at a third-party manufacturing facility as its main reason for not approving the therapy at that time. Braeburn representatives said the company has worked closely with the unnamed third-party… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 16, 2021 Category: Biotechnology Authors: John George Source Type: news

Alembic Pharma JV Aleor Dermaceuticals gets USFDA nod for testosterone topical solution
Aleor Dermaceuticals has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation, Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - June 16, 2021 Category: Pharmaceuticals Source Type: news

Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis
WILMINGTON, Del.--(BUSINESS WIRE) June 11, 2021 -- Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 11, 2021 Category: Drugs & Pharmacology Source Type: news

Adamis Provides Update on Zimhi
SAN DIEGO, June 09, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s resubmitted New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 9, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity
PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2021 Category: Drugs & Pharmacology Source Type: news

BeyondSpring Announces U.S. FDA Acceptance And Priority Review Of New Drug Application For Plinabulin And G-CSF Combination For The Prevention Of Chemotherapy-Induced Neutropenia (CIN)
NEW YORK, June 01, 2021 (GLOBE NEWSWIRE)— BeyondSpring Inc. (the“Company” or“BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis
SEATTLE, June 1, 2021 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, and its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
DURHAM, N.C.--(BUSINESS WIRE) June 01, 2021 -- Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

FDA extends deadline for review of Verrica Pharmaceuticals' lead drug candidate
The West Chester pharmaceutical company is going to have to wait a little longer for a decision on its new drug application. (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - May 28, 2021 Category: Health Management Authors: John George Source Type: news

Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)
PARIS, FRANCE, 28 May 2021– Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals Announces Extension of FDA Review Period of its NDA for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA– May 28, 2021 (GLOBE NEWSWIRE)– Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark
Research Triangle Park, NC, May 28, 2021– Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

Common Labeling Deficiencies and Tips for Generic Drug Applications - 05/07/2021 - 05/07/2021
FDA will discuss the most common labeling mistakes found in Abbreviated New Drug Applications (ANDAs) and how to avoid them and other labeling tips. FDA will also provide answers to common labeling questions asked by generic drug applicants. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - May 27, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Camcevi (leuprolide mesylate) for the Treatment of Advanced Prostate Cancer
TAIPEI, May 26, 2021 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ( " Foresee " ) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Camcevi 42 mg, a ready-to-use 6-month subcutaneous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 26, 2021 Category: Drugs & Pharmacology Source Type: news

Zydus Cadila, Taiwan's TLC ink pact to market black fungus drug in India
The Central Drugs Standard Control Organization has approved the new drug application (NDA) of TLC for Amphotericin B Liposome for Injection 50mg for immediate importation as per approved usage and indication, Zydus Cadila said. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - May 26, 2021 Category: Pharmaceuticals Source Type: news

TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
NEW YORK, May 25, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 25, 2021 Category: Drugs & Pharmacology Source Type: news

BioXcel Therapeutics Announces FDA Acceptance for Filing of NDA for BXCL501 for the Acute Treatment of Agitation Associated with Schizophrenia and Bipolar Disorders I and II
NEW HAVEN, Conn., May 19, 2021 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. ( " BioXcel " or the " Company " ) (Nasdaq: BTAI), a clinical-stage biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 19, 2021 Category: Drugs & Pharmacology Source Type: news

Adamis Pharmaceuticals Resubmits Zimhi New Drug Application to FDA for the Treatment of Opioid Overdose
SAN DIEGO, May 17, 2021 (GLOBE NEWSWIRE) -- Adamis Pharmaceuticals Corporation (NASDAQ: ADMP), a biopharmaceutical company developing and commercializing specialty products for respiratory disease, allergy and opioid overdose, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 17, 2021 Category: Drugs & Pharmacology Source Type: news

Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for Recorlev (levoketoconazole) for the Treatment of Endogenous Cushing ’s Syndrome
DUBLIN, Ireland and TREVOSE, Pa., May 13, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 17, 2021 Category: Drugs & Pharmacology Source Type: news

Late-Breaking Data at ACC.21 Show XARELTO ® (rivaroxaban) Plus Aspirin Significantly Reduced Total Ischemic Events in Peripheral Artery Disease (PAD) Patients After Lower-Extremity Revascularization
RARITAN, N.J., May 16, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today presented new data from the Phase 3 VOYAGER PAD study which showed XARELTO® (rivaroxaban) (2.5 mg twice daily) in combination with aspirin (100 mg once daily) consistently reduced severe vascular events in patients with peripheral artery disease (PAD) after lower-extremity revascularization (LER) compared to aspirin alone regardless of whether it was the first, second, third, or subsequent event. The primary results of VOYAGER PAD showed that XARELTO® plus aspirin reduced first events by 15 percent among patients...
Source: Johnson and Johnson - May 16, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Amgen Announces Tezepelumab Biologics License Application Submitted To U.S. FDA
THOUSAND OAKS, Calif., May 10, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced its partner AstraZeneca (NASDAQ:AZN) submitted a Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 10, 2021 Category: Drugs & Pharmacology Source Type: news

Liquidia Resubmits New Drug Application for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
MORRISVILLE, N.C., May 10, 2021 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) announced today that on May 7, 2021, it resubmitted its New Drug Application (NDA) for LIQ861 for the treatment of pulmonary arterial... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 10, 2021 Category: Drugs & Pharmacology Source Type: news

Vertex-partnered gene therapy startup raises $110M
Affinia Therapeutics, the gene therapy startup founded in 2019 based on research out of Massachusetts Eye and Ear and Harvard Medical School, has raised $110 million as it looks to file its first new drug application within the next year. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - May 3, 2021 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news

Clearside Biomedical Announces Resubmission of New Drug Application for Xipere for Treatment of Macular Edema Associated with Uveitis
ALPHARETTA, Ga., May 03, 2021 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 3, 2021 Category: Drugs & Pharmacology Source Type: news

Takeda Announces U.S. FDA Grants Priority Review for New Drug Application for Mobocertinib (TAK-788) as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer
CAMBRIDGE, Mass.& OSAKA, Japan--(BUSINESS WIRE) April 27, 2021-- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 27, 2021 Category: Drugs & Pharmacology Source Type: news

Reata Announces FDA Accepted for Filing the NDA for Bardoxolone for the Treatment of Patients With Chronic Kidney Disease Caused by Alport Syndrome
PLANO, Texas, April 26, 2021 (GLOBE NEWSWIRE) -- Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (“Reata,” the“Company,” or“we”), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 26, 2021 Category: Drugs & Pharmacology Source Type: news

Axsome Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for AXS-05 for Treatment of Major Depressive Disorder
NEW YORK, April 26, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 26, 2021 Category: Drugs & Pharmacology Source Type: news

Johnson & Johnson Reports 2021 First-Quarter Results
New Brunswick, N.J. (April 20, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for first-quarter 2021. “Johnson & Johnson delivered a strong first quarter performance led by the above market growth of our Pharmaceutical business and continued recovery in Medical Devices,” said Alex Gorsky, Chairman and Chief Executive Officer. “The ability to deliver these results while simultaneously advancing our robust pipeline of life-enhancing medicines, products and solutions during these times is a testament to the strength and resilience of our business and the dedication of the 135,000...
Source: Johnson and Johnson - April 20, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Genmab and Seagen Announce U.S. FDA Filing Acceptance for Priority Review of Tisotumab Vedotin Biologics License Application for Patients with Recurrent or Metastatic Cervical Cancer
COPENHAGEN, Denmark and BOTHELL, Wash.; April 09, 2021– Genmab A/S (Nasdaq: GMAB) and Seagen Inc. (Nasdaq: SGEN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 9, 2021 Category: Drugs & Pharmacology Source Type: news

Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis
NEW YORK--(BUSINESS WIRE) April 07, 2021 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - April 7, 2021 Category: Drugs & Pharmacology Source Type: news

Mineralys Therapeutics Closes $40 Million Series A Funding
Financing Co-led by HBM Healthcare Investments and Samsara BioCapital Food and Drug Administration Accepts Investigational New Drug Application for MLS-101 and Advances to Phase 2 Proof-of-Concept Clinical Trial Company Announces Jon Congleton as Chi... Biopharmaceuticals, Cardiology, Venture Capital, Personnel Mineralys Therapeutics, aldosterone synthase, hypertension (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - April 6, 2021 Category: Pharmaceuticals Source Type: news

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - April 5, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - April 1, 2021 Category: Health Management Authors: Rebecca Cooper Source Type: news

United Therapeutics gets another FDA approval for pulmonary hypertension therapy
United Therapeutics (NASDAQ: UTHR) has received another Food and Drug Administration approval for Tyvaso more than a decade after the agency first approved the therapy for treatment of pulmonary arterial hypertension.   The FDA approved a supplemental new drug application for the use of Tyvaso Inhalation Solution, an inhaled form of the drug trepostinil, to increase exercise ability in patients with pulmonary hypertension resulting from interstitial lung disease (PH-ILD), United Therapeutics said… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - April 1, 2021 Category: Biotechnology Authors: Rebecca Cooper Source Type: news