Blogarama: The Oldest Blog Directory

( click to enlarge )I called  Liminal BioSciences Inc (NASDAQ:LMNL) recently at $4.40 as a potential big runner due to the PDUFA catalyst. On Friday, just a few minutes before the close… Read More

COPENHAGEN, Denmark, June 11, 2021 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technologies to create… Read More

From the perspective of history and research, the new drug report 2020 introduced 148 kinds of chemical entities, biological agents and product development approved and marketed in various c… Read More

An investigation on behalf of current long term investors in Kadmon Holdings Inc (NYSE: KDMN) shares. An investigation was announced concerning potential breaches of fiduciary duties by… Read More

13 Anti-tumor drugs Trastuzumab deruxtecan (Enhertu), an antibody drug conjugate (ADC) developed by Japan’s Daiichi Sankyo and authorized by AstraZeneca for co-development and comme… Read More

The Hourly View for Merck Currently, MRK’s price is up $0.03 (0.04%) from the hour prior. The hourly chart shows that Merck has seen 2 straight up hours. As for the trend on the hourly… Read More

Urinary Tract infection (UTI) is the most common bacterial infection caused by a wide range of pathogens such as Escherichia coli, Klebsiella pneumonia, proteus miravillis, Enterococcus faec… Read More

( click to enlarge )FuelCell Energy Inc (NASDAQ:FCEL) Good solid stock moving higher on expansion volume. 7.86 is the pivot here. If it breaks, we could see 8.50 quickly. Use the rising EMA2… Read More

Los Angeles, California--(Newsfile Corp. - December 3, 2021) -  The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf o… Read More

DUBLIN–(BUSINESS WIRE)–The “Market Spotlight: Hypogonadism” report has been added to ResearchAndMarkets.com’s offering. This Market Spotlight report covers… Read More

Immunocore, a commercial-stage biotechnology company developing T cell receptor (TCR)-based immunotherapies in oncology, autoimmune and infectious diseases, has won approval from the US Food… Read More

Salt Lake City, Utah--(Newsfile Corp. - March 18, 2022) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), ("Kiora" or the "Company") has received Orphan Drug Designation from the U.S. Food and D… Read More

New York, New York--(Newsfile Corp. - April 1, 2022) - Pomerantz LLP announces that a class action lawsuit has been filed against Fennec Pharmaceuticals Inc. ("Fennec" or the "Company") (NAS… Read More

TOKYO and CAMBRIDGE, Mass., May 9, 2022 /PRNewswire/ — Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. BIIB Corporate headquarters: Camb… Read More

Gilead Sciences, Inc. has announced the submission of a New Drug Application(NDA) to the US Food and Drug Association(FDA) for “Lenacapavir” to fight against HIV-1. The NDA is su… Read More

We are at mid-year, a good time to check in and see how we are doing on a number of fronts – including where we are with new drug approvals. Over the years, Congress has acted to enhan… Read More

ICER Weekly View View as Webpage Sign up for ICER's Weekly View Newsletter… Read More

Byondis announced that the US Food and Drug Administration (FDA) accepted their Biologics License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985), an investigational therapy be… Read More

On the second attempt, Azurity Pharmaceuticals was able to secure an FDA nod for its zonisamide oral suspension, making it the first firm to do so in the United States. In February 2021… Read More

The US Food and Drug Administration (FDA) has approved AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab-deruxtecan) for the treatment of patients with unresectable or metastatic H… Read More

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from 2L and 3L ER+/HER2- advanced or metastatic breast ca… Read More

ICER Weekly View View as Webpage Sign up for ICER's Weekly View Newsletter… Read More

hapabapa/iStock Editorial through Getty Photos Highlighting the drawbacks of the FDA’s accelerated approval, a newly printed examine has discovered that medicines for under 75% of… Read More

STOCKHOLM, Sept. 28, 2022 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced positive topline results for the large global Phase 3 confirmatory… Read More

AntonioSolano/iStock by way of Getty Photographs Citi has opened 90-day catalyst watches on 4 of its buy-rated biotechs, underscoring their potential to generate main catalysts in This fa… Read More

ICER Weekly View View as Webpage Sign up for ICER's Weekly View Newsletter   Weekly View November 11, 2022 From the desk of Priya Rana… Read More

| (PHOTO: REUTERS)The Food and Drug Administration has indefinitely postponed a meeting scheduled for this Friday to review an application for the first over-the-counter birth control pill… Read More

TipRanks Billionaire David Shaw Pours Money Into 3 “Strong Buy” Stocks Are the tides turning on Wall Street? Stocks fell in the past three trading sessions, as investors abandon… Read More

TipRanks Billionaire David Shaw Pours Money Into 3 “Strong Buy” Stocks Are the tides turning on Wall Street? Stocks fell in the past three trading sessions, as investors abandon… Read More

STOCKHOLM, Dec. 23, 2022 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have initiated submission of data for Biologics License Ap… Read More

The life sciences and healthcare are among the biggest industries globally, and their significance was particularly highlighted during the past couple of years by the COVID-19 pandemic. Give… Read More

Age-related Macular Degeneration Market Growth & Trends The global age-related macular degeneration market size is expected to reach USD 17.99 billion by 2030, according to a new… Read More

– Mean Annualized Bleed Rate Reduced by 80% from Baseline and Factor VIII Usage Reduced by 94% in Year 3 Compared to Baseline   – 92% of Patients off Prophylaxis at the En… Read More

Shares of Krystal Biotech Inc. KRYS fell 9.5% in premarket trading on Monday after the company said the Food and Drug Administration moved back the decision date for its experimental treatme… Read More

New York, New York--(Newsfile Corp. - February 2, 2023) - Pomerantz LLP is investigating claims on behalf of investors of Phathom Pharmaceuticals, Inc. ("Phathom" or the "Company") (NASDAQ:… Read More

ICER Weekly View View as Webpage Sign up for ICER's Weekly View Newsletter   Weekly View February 24, 2023 From the desk of Priya Ranade… Read More

Compelling clinical data with clear paths to products and multiple near‐term value-creating catalystsComplementary technology platforms designed to treat solid tumors which represents… Read More

   Ipsen receives new FDA PDUFA date for investigational palovarotene for the treatment of people with FOP PDUFA date has been set for 16 August 2023 following the New Drug Appl… Read More

Fortress expects to file a total of three new drug applications in 2023 Record consolidated net revenue of $75.7 million for full-year 2022 FDA accepted for filing the Biologics License A… Read More

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental New Drug Applications (sNDAs) for BRAFTOVI® (encorafeni… Read More

FDA 21 CFR Part 312| Requirements | Inspection | Audit Checklist The Food and Drug Administration (FDA) established a collection of rules and specifications known as 21 C… Read More

-Companies to Create World-Class Ophthalmology Entity- -Lead Program, Avacincaptad Pegol for the Potential Treatment of Geographic Atrophy with PDUFA Goal Date of August 19, 2023–… Read More

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal cancers TOKYO, July 6, 2023 /PRNewswire/ — Astella… Read More

Santhera expects to maximise the reduced financial burden of the Raxone development programme to focus on vamorolone’s European launch. Credit: MIRCO EMMY / Shutter… Read More

Financiamento de US$ 18 Milhões para Desenvolvimento de Vacina de RNA contra Chikungunya em SeattleAtualmente, não há tratamentos aprovados para chikungunya, uma doen&cc… Read More

Company is well capitalized after signing $50 million working capital credit facility and recent $30 million equity raise Favorable outcome at Markman hearing in pending CINVANTI® ANDA… Read More

The US Food and Drug Administration (FDA) has accepted cefepime-taniborbactam antibiotic combination for priority review for treatment of complicated urinary tract infections (cUTIs). The dr… Read More

Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of… Read More

Part two: Industry examining FDA guidance on nitrosamines This summer, a wave of regulatory activity on nitrosamines has taken place, with agencies from around the world recentl… Read More

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a new Biologics License A… Read More

What happened Shares of Ardelyx (ARDX -14.49%) were down more than 12% as of 3:30 p.m. on Wednesday. The healthcare company, which has a chronic kidney disease (CKD) drug that is awaitin… Read More