Fabre-Kramer Pharmaceuticals Announces FDA Acceptance of NDA Resubmission as Complete Response and Assignment of PDUFA Regulatory Action Date
HOUSTON, Jan. 24, 2023 -- Fabre-Kramer Pharmaceuticals, a leading developer of novel small molecule medications to address unmet needs in the treatment of psychiatric and neurological disorders, announced today it received on January 20, 2023... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 24, 2023 Category: Drugs & Pharmacology Source Type: news

Eli Lilly ’ s Alzheimer ’s Drug Donanemab Fails to Get Early FDA Approval
Eli Lilly & Co.’s bid for accelerated approval of its Alzheimer’s therapy donanemab was rejected by U.S. regulators, an unexpected setback for the drugmaker. The Food and Drug Administration sent the company a complete response letter saying it would not give the early approval for the drug because not enough patients on the trial had received it for a full 12 months, Lilly said Thursday in a statement. The agency wanted Lilly to provide safety data on at least 100 patients who had been on the drug for a year. Lilly’s application for accelerated approval was based on a relatively small mid-stage trial...
Source: TIME: Health - January 20, 2023 Category: Consumer Health News Authors: Robert Langreth and Nacha Cattan/Bloomberg Tags: Uncategorized bloomberg wire Drugs Source Type: news

Santhera and ReveraGen Announce FDA Acceptance of New Drug Application for Vamorolone in Duchenne Muscular Dystrophy
Pratteln, Switzerland, and Rockville, MD, USA, January 9, 2023– Santhera Pharmaceuticals (SIX: SANN) and ReveraGen BioPharma, Inc announce that the U.S. Food and Drug Administration (FDA) has accepted the new drug application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 9, 2023 Category: Drugs & Pharmacology Source Type: news

Novan Submits New Drug Application to the U.S. FDA for Berdazimer Gel, 10.3% (SB206) for the Treatment of Molluscum Contagiosum
DURHAM, N.C., Jan. 06, 2023— Novan, Inc. (“the Company” or“Novan”) (Nasdaq: NOVN), announced today that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 6, 2023 Category: Drugs & Pharmacology Source Type: news

Nirsevimab US Regulatory Submission Accepted for the Prevention of RSV Lower Respiratory Tract Disease in Infants and Children up to Age 24 Months
5 January 2023 -- Nirsevimab is being developed and commercialised by AstraZeneca in collaboration with Sanofi and is the first single-dose preventative option for the broad infant population, including those born healthy, at term or preterm, or... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 5, 2023 Category: Drugs & Pharmacology Source Type: news

Checkpoint Therapeutics Submits Biologics License Application to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
WALTHAM, Mass., Jan. 04, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, today announced the submission of a Biologics License... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2023 Category: Drugs & Pharmacology Source Type: news

Fabre-Kramer Submits NDA Amendment for Exxua ™ for Treatment of Major Depressive Disorder
HOUSTON, Jan. 4, 2023 /PRNewswire/— Fabre-Kramer Pharmaceuticals, Inc. (Fabre-Kramer) today announced that on December 23, 2022, it filed an NDA Amendment with the Food and Drug Administration (FDA) for its novel mechanism antidepressant... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 4, 2023 Category: Drugs & Pharmacology Source Type: news

Orasis Pharmaceuticals Submits New Drug Application for Investigational Novel Eye Drop Candidate, CSF-1, for the Treatment of Presbyopia
Ponte Vedra, FL, January 3, 2023– Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on developing a unique eye drop to improve near vision for people with presbyopia, today announced that it has submitted a New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 3, 2023 Category: Drugs & Pharmacology Source Type: news

Phathom Pharmaceuticals Provides Update on New Drug Application Review of Vonoprazan for Erosive Esophagitis
FLORHAM PARK, N.J., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases and disorders, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - January 3, 2023 Category: Drugs & Pharmacology Source Type: news

The Petri Dish: Group eyes Biogen Alzheimer's drug price, FDA rejects psych drug application
The FDA has elected not to accept a new drug application from Minerva Neurosciences Inc., sending shares plummeting. Read this, and more, in the latest biotech news roundup, The Petri Dish. (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - December 29, 2022 Category: Pharmaceuticals Authors: Rowan Walrath Source Type: news

Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia
BURLINGTON, Mass., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 28, 2022 Category: Drugs & Pharmacology Source Type: news

SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Nirogacestat for the Treatment of Adults with Desmoid Tumors
STAMFORD, Conn., Dec. 27, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 27, 2022 Category: Drugs & Pharmacology Source Type: news

Harm Reduction Therapeutics' New Drug Application for RiVive(TM) Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA
Low-cost, over-the-counter naloxone nasal spray advances to FDA review. Approval would increase access to this lifesaving medicine for the emergency treatment of opioid overdose. PITTSBURGH, Dec. 26, 2022 -- (Healthcare Sales & Marketing Network) -- Ha... Biopharmaceuticals, Drug Delivery, FDA Harm Reduction Therapeutics, RiVive, intranasal, naloxone (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - December 26, 2022 Category: Pharmaceuticals Source Type: news

Pfizer announces FDA and EMA acceptance of etrasimod regulatory submissions for ulcerative colitis
Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis (UC). The FDA's decision is expected in the second half of 2023. The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with the decision anticipated in the first half of 2024. (Source: World Pharma News)
Source: World Pharma News - December 26, 2022 Category: Pharmaceuticals Tags: Featured Pfizer Business and Industry Source Type: news

Alembic Pharma gets USFDA nod for generic drug to treat breast cancer
The approval granted by the US Food& Drug Administration (USFDA) is for the abbreviated new drug application (ANDA), Fulvestrant injection of strength 250 mg/5 mL (50 mg/mL) per single-dose prefilled syringe, the company said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - December 26, 2022 Category: Pharmaceuticals Source Type: news