Johnson & Johnson Reports 2020 Fourth-Quarter and Full Year Results
New Brunswick, N.J. (January 26, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for fourth-quarter and full year 2020. “Our notable full year performance reflects the continued confidence from patients, physicians, customers and consumers in our life-enhancing products and medicines, particularly throughout the COVID-19 pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m incredibly proud of our Johnson & Johnson teams around the world for going above and beyond to meet stakeholder needs. These efforts, and our commitment to families around the world a...
Source: Johnson and Johnson - January 26, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Strides Pharma gets USFDA nod for generic drug
Bengaluru-based Strides Pharma has 127 cumulative abbreviated new drug applications (ANDA) filings with USFDA of which 96 have been approved and 31 are pending approval. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 25, 2021 Category: Pharmaceuticals Source Type: news

FDA grants priority review to Roche ’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
Basel, 21 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company ’s supplemental New Drug Application (sNDA) and granted Priority Review for Esbriet® (pirfenidone) for the treatment of unclassifiable interstitial lung disease (UILD). The FDA is expected to make a decision on approval by May 2021.“Since its US approval, Esbriet has become a standard of care for people living with idiopathic pulmonary fibrosis. However, significant unmet need remains in fibrotic lung diseases, including unclassifiable interstitial lung disease ...
Source: Roche Investor Update - January 21, 2021 Category: Pharmaceuticals Source Type: news

FDA Welcomes Sotagliflozin Data for Heart Failure in Diabetes FDA Welcomes Sotagliflozin Data for Heart Failure in Diabetes
The FDA says data from two pivotal trials can be used to help support a new drug application for the dual SGLT1/2 inhibitor, according to a statement by Lexicon Pharmaceuticals.Medscape Medical News (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - January 15, 2021 Category: Cardiology Tags: Diabetes & Endocrinology News Source Type: news

Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 15, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pfizer ’s Xalkori (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults
NEW YORK--(BUSINESS WIRE) January 14, 2021 -- Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for Xalkori® (crizotinib) for the treatment of pediatric... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - January 14, 2021 Category: Drugs & Pharmacology Source Type: news

Unichem Labs gets American drug regulator's nod to market generic Celecoxib capsules
The company has received abbreviated new drug application (ANDA) approval for its Celecoxib capsules in the strengths of 50 mg, 100 mg, 200 mg, and 400 mg from the United States Food and Drug Administration (USFDA), Unichem said in a filing to BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2021 Category: Pharmaceuticals Source Type: news

Granules gets American drug regulator's nod for diabetes management drug Metformin
The US Food and Drug Administration (USFDA) has granted final approval for the company's abbreviated new drug application (ANDA) for Metformin Hydrochloride extended-release tablets USP, 500 mg and 1000 mg, Granules said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 13, 2021 Category: Pharmaceuticals Source Type: news

US-FDA-grants-priority-review-New-Drug-Application-finerenone-treat-patients-chronic-kidney-disease
(Source: Bayer Company News)
Source: Bayer Company News - January 12, 2021 Category: Pharmaceuticals Source Type: news

JB Chemicals gets USFDA nod for generic product
The US Food and Drug Administration (USFDA) has approved company's abbreviated new drug application (ANDA) for Loratadine tablets USP 10 mg for treatment of allergic rhinitis caused by pollen and upper respiratory tract allergy, JB Chemicals and Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - January 8, 2021 Category: Pharmaceuticals Source Type: news

Marius Pharmaceuticals Submits New Drug Application to U.S. FDA for Kyzatrex Next-generation Oral Testosterone Replacement Therapy in Male Patients with Hypogonadism
Raleigh, N.C., Jan. 5, 2021— Marius Pharmaceuticals, a specialty pharmaceutical company focusing on treating conditions that are primarily associated with testosterone deficiency, today announced that it has submitted a New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 5, 2021 Category: Drugs & Pharmacology Source Type: news

US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency
 NEW YORK& MIAMI--(BUSINESS WIRE) Monday, January 04, 2021 -- Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the US Food and Drug Administration (FDA) has accepted for filing the initial Biologics License... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2021 Category: Drugs & Pharmacology Source Type: news

Pittsburgh-based LyGenesis receives FDA clearance for new drug application
Pittsburgh-based LyGenesis Inc. received U.S. Food and Drug Administration clearance for its Investigational New Drug application, according to a news release. LyGenesis was founded to develop cell therapies to enable organ regeneration. With this new application, LyGenesis will move forward with a Phase 2a study on the safety, tolerance and efficacy of its novel cell therapy for end stage liver disease, according to the release.  LyGenesis also recent ly finalized $11 million in private financing… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - December 31, 2020 Category: American Health Authors: Julia Mericle Source Type: news

FDA Accepts Alkermes' Resubmission of New Drug Application for ALKS 3831
DUBLIN, Dec. 29, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company's New Drug Application (NDA) resubmission for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 29, 2020 Category: Drugs & Pharmacology Source Type: news

Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi
NEW YORK--(BUSINESS WIRE)--Dec. 29, 2020-- Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 29, 2020 Category: Drugs & Pharmacology Source Type: news

Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
STAMFORD, Conn., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2020 Category: Drugs & Pharmacology Source Type: news

Chi-Med Initiates Rolling Submission of NDA to U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Hong Kong, Shanghai,& Florham Park, NJ: Monday, December 28, 2020: Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM) today announces that it has initiated the filing of a New Drug Application (“NDA”) to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2020 Category: Drugs & Pharmacology Source Type: news

Verrica Pharmaceuticals resubmits application for lead drug candidate
A Chester County pharmaceutical company specializing in developing treatment for skin diseases has resubmitted a new drug application for its lead product candidate after being rejected by the Food and Drug Administration earlier this year. Verrica Pharmaceuticals (NASDAQ: VRCA) of West Chester resubmitted its application for VP-102, an experimental treatment for molluscum contagiosum. The company's stock opened up about 2.5% at $12.94 per share Thursday. “We look forward to working with the… (Source: bizjournals.com Health Care News Headlines)
Source: bizjournals.com Health Care News Headlines - December 24, 2020 Category: Health Management Authors: John George Source Type: news

Verrica Pharmaceuticals Announces Resubmission of New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, PA– Dec. 23, 2020 (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 - December 23, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB)
IRVINE, Calif.& BASEL, Switzerland--(BUSINESS WIRE)--Dec. 23, 2020-- Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 23, 2020 Category: Drugs & Pharmacology Source Type: news

Novartis Receives FDA Complete Response Letter on Inclisiran Novartis Receives FDA Complete Response Letter on Inclisiran
The FDA was unable to approve the new drug application for inclisiran, a novel treatment to lower LDL cholesterol, owing to unresolved facility inspection concerns, the company said.News Alerts (Source: Medscape Cardiology Headlines)
Source: Medscape Cardiology Headlines - December 22, 2020 Category: Cardiology Tags: Cardiology News Source Type: news

FDA Approves Supplemental New Drug Application for Takeda ’s Iclusig (ponatinib) for Adult Patients with Resistant or Intolerant Chronic-Phase CML
December 18, 2020 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 18, 2020 Category: Drugs & Pharmacology Source Type: news

Zynerba provides progress report on its potential Fragile X syndrome therapy
Zynerba Pharmaceuticals, a developer of synthetic and transdermal cannabinoid therapies for rare neuropsychiatric disorders, said Thursday it expects to begin a "pivotal" late-stage clinical trial of its experimental Fragile X syndrome therapy Zygel late next year. The leaders of the 13-year-old Devon company said they believe positive results from the trial, to confirm previous study results, would be sufficient to support the submission of a new drug application for Zygel to treat Fragile X. Zynerba's… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - December 17, 2020 Category: Biotechnology Authors: John George Source Type: news

BAT progresses COVID-19 candidate vaccine into Phase I human clinical trials
(R&D at British American Tobacco) BAT's US Bio-tech arm, Kentucky BioProcessing (KBP) today announced plans to commence a Phase I first-time-in-human study of its COVID-19 vaccine candidate following approval of its Investigational New Drug application by the US Food and Drug Administration (FDA). Enrolment for the study is expected to begin shortly. (Source: EurekAlert! - Medicine and Health)
Source: EurekAlert! - Medicine and Health - December 16, 2020 Category: International Medicine & Public Health Source Type: news

U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda ’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis
Osaka, JAPAN, December 15, 2020– Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted for review the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 15, 2020 Category: Drugs & Pharmacology Source Type: news

Alembic Pharma gets USFDA nod for bipolar disorder treatment drug
In a regulatory filing, Alembic Pharmaceuticals said it has received approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Asenapine Sublingual Tablets in the strengths of 5 mg and 10 mg. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 11, 2020 Category: Pharmaceuticals Source Type: news

Atox Bio Announces FDA Acceptance to File the NDA for Reltecimod to Treat Suspected Organ Dysfunction or Failure in Patients with Necrotizing Soft Tissue Infection ( " Flesh-Eating Disease " )
DURHAM, N.C. and NESS ZIONA, Israel, Dec. 10, 2020 /PRNewswire/ -- Atox Bio today announced that the U.S. Food and Drug Administration (FDA) has accepted to file the New Drug Application (NDA) for reltecimod with a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 10, 2020 Category: Drugs & Pharmacology Source Type: news

Amgen's Sotorasib Granted Breakthrough Therapy Designation for Advanced or Metastatic Non-Small Cell Lung Cancer Patients with KRAS G12C Mutation
Sotorasib Also Accepted Into FDA's Real-Time Oncology Review Pilot Program New Drug Application Submission to FDA Planned by End of the Year THOUSAND OAKS, Calif., Dec. 8, 2020 -- (Healthcare Sales & Marketing Network) -- Amgen (NASDAQ: AMGN) today ... Biopharmaceuticals, Oncology, FDA Amgen, Sotorasib, Non-Small Cell Lung Cancer, KRAS (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 8, 2020 Category: Pharmaceuticals Source Type: news

Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC
BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced it has submitted a New Drug Application (NDA) to... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2020 Category: Drugs & Pharmacology Source Type: news

Lipocine Announces Tentative Approval of TLANDO
SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/— Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 8, 2020 Category: Drugs & Pharmacology Source Type: news

Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris
NESS ZIONA, Israel, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

scPharmaceuticals Inc. Receives Complete Response Letter from FDA for Furoscix
BURLINGTON, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

Scynexis Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections
JERSEY CITY, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc.,  (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox
DURHAM, N.C., Dec. 07, 2020 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 7, 2020 Category: Drugs & Pharmacology Source Type: news

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
RARITAN, N.J., December 3, 2020 – The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 3, 2020 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia
NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the Company has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma
PALO ALTO, CA– December 1, 2020– BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 1, 2020 Category: Drugs & Pharmacology Source Type: news

Kadmon Announces FDA Acceptance of NDA for Belumosudil in Patients With Chronic Graft-Versus-Host Disease
NEW YORK, NY / ACCESSWIRE / November 30, 2020 / Kadmon Holdings, Inc. (NASDAQ:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 30, 2020 Category: Drugs & Pharmacology Source Type: news

Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the Company), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 30, 2020 Category: Drugs & Pharmacology Source Type: news

Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension
RESEARCH TRIANGLE PARK, N.C., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Liquidia Technologies, Inc., a wholly owned subsidiary of Liquidia Corporation (NASDAQ: LQDA), today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 25, 2020 Category: Drugs & Pharmacology Source Type: news

Alembic Pharma's JV Aleor Dermaceuticals gets tentative nod from USFDA for testosterone gel
Aleor Dermaceuticals has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Testosterone Gel, 1.62 per cent (20.25 mg/1.25 gm actuation), Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 25, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
             Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dos...
Source: Roche Media News - November 24, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person
             Basel, 24 November 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza ® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.“With today’s approval, Xofluza is now available as the first single-dos...
Source: Roche Investor Update - November 24, 2020 Category: Pharmaceuticals Source Type: news

Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person
South San Francisco, CA -- November 23, 2020 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - November 23, 2020 Category: Drugs & Pharmacology Source Type: news

Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND
This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - November 18, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed
Berkeley Heights, NJ– November 18, 2020 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 18, 2020 Category: Drugs & Pharmacology Source Type: news

Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review
DUBLIN, Nov. 17, 2020 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 17, 2020 Category: Drugs & Pharmacology Source Type: news

Pfizer moves US court against Aurobindo Pharma, Dr Reddy's on cancer drug
In March 2019, several generic companies notified us that they had filed abbreviated new drug applications with the US Food and Drug Administration (FDA) seeking approval to market generic versions of Ibrance. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - November 17, 2020 Category: Pharmaceuticals Source Type: news

Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of PNH
WALTHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals,  Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - November 16, 2020 Category: Drugs & Pharmacology Source Type: news