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Category: FDA


FDA, Regulations

FDA Agrees to Use of New Manufacturing Process for Nomacopan in Clinical Studies

January 19, 2022

Via: Contract Pharma

Akari Therapeutics, Plc, a late-stage biopharmaceutical company focused on therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, has announced that the U.S. Food and Drug Administration ( FDA ) has agreed, […]


FDA, Regulations

Senate Committee Backs Califf Nomination to Head FDA

January 14, 2022

Via: Drugs.com

The nomination of former U.S. Food and Drug Administration head Dr. Robert Califf to again lead the agency now heads to the full Senate for a vote, after a Senate committee on Thursday voted 13-8 for approval. Among those who […]


FDA, Regulations

FDA Keeps New Drugs Coming

January 5, 2022

Via: Biopharm International

Despite major challenges and demands created by the coronavirus pandemic, FDA maintained a steady pace in 2021 in approving important new therapies for market, including new vaccines and treatments for COVID-19. Last year saw the Center for Drug Evaluation and […]


FDA, Regulations

FDA Expands Use of Pfizer-BioNTech COVID-19 Vaccine

January 3, 2022

Via: Biopharm International

FDA announced on Jan. 3, 2022, that it was amending the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to expand single booster doses to children 12 through 15 years of age. The agency reviewed data from Israel from […]


FDA, Regulations

Janssen Submits Biologics License Application to U.S. FDA Seeking Approval of Teclistamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

December 29, 2021

Via: Drugs.com

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 teclistamab for the treatment of patients with relapsed or refractory (R/R) […]


FDA, Regulations

FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults

December 27, 2021

Via: World Pharma News

The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for […]


FDA, Regulations

Relief for AZ, Amgen as FDA okays severe asthma hope tezepelumab

December 20, 2021

Via: Pharmaphorum

Another phase 3 study supported the efficacy of the first-in-class TSLP inhibitor as an add-on treatment for people aged 12 and over with severe asthma, as did an earlier phase 2 trial, but the miss raised questions about the drug’s […]


FDA, Regulations

FDA Allows Abortion Pill, Mifepristone, to Stay Available by Mail

December 17, 2021

Via: Drugs.com

Access to abortion pills by mail was made permanent by the U.S. Food and Drug Administration on Thursday. Patients will be able to have a telemedicine appointment with a provider who can prescribe the pills and send them to the […]


FDA, Regulations

FDA approves first drug to prevent graft-versus-host disease

December 16, 2021

Via: PMLiVE

Huge strides have been made since then and haematopoietic stem cell transplantation (HSCT) is now an effective treatment –even a cure– for haematological malignancies and other non-malignant haematological diseases. Yet, up to 70% of patients that receive stem cell transplants, […]


FDA

FDA sets April date for verdict on Incyte’s vitiligo drug

December 15, 2021

Via: Pharmaphorum

The FDA has kicked off a priority review of Opzelura (ruxolitinib), a JAK1/JAK2 inhibitor it approved to treat atopic dermatitis in September, and aims to decide on the vitiligo indication by 18 April next year. If approved, Opzelura would provide […]


FDA, Regulations

FDA authorises Evusheld for COVID-19 prevention

December 9, 2021

Via: European Pharmaceutical Review

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis of COVID-19 in certain adults and paediatric individuals (12 years of age […]


FDA, Regulations

Keytruda gains eighth FDA approval this year

December 7, 2021

Via: PMLiVE

In its eighth US approval of the year, the Food and Drug Administration (FDA) has given the green light to use Keytruda as an adjuvant treatment for adults and children aged 12 years and over who have stage 2b and […]