關於 fda approval 2021 ，我們在網路上蒐集到這些相關的討論、資訊與評價

#11. New FDA Drug & Device Approvals | BioSpace

12/21/2021. The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. FDA has approved two pediatric indications for XARELTO®: the ...

#12. US FDA approves AstraZeneca-Amgen drug for severe asthma

December 17, 20213:19 PM PSTLast Updated 4 days ago ... U.S. FDA approves AstraZeneca-Amgen drug for severe asthma. Reuters. 2 minute read.

#13. Top June 2021 FDA Approvals - Clinical Advisor

Top June 2021 FDA Approvals · Aduhelm for Alzheimer Disease · Tembexa for Smallpox · Wegovy for Weight Management · Brexafemme for Candidiasis.

#14. FDA Drug Approvals — 2021 Midyear Review - Medscape ...

Stay current on FDA drug approvals in 2021. ... The FDA granted accelerated approval for aducanumab based on the reduction in amyloid-beta ...

#15. FDA Calendar of Biotech Stock Catalysts • BioPharmCatalyst

Ticker Price Stage last updated AQST $6.22 +0.52 +9.12% PDUFA 11/02/2021 NVO $103.53 ‑3.92 ‑3.65% Phase 1/2 11/16/2021 INCY $73.45 +0.56 +0.77% PDUFA 10/27/2021

#16. The big approvals still on the cards for 2021 | Evaluate

Biogen got a win last week with US approval of its Alzheimer's ... to the FDA's complete response letter for Leqvio, making a 2021 decision ...

#17. Recent Trends in Approvals of Novel Drugs - US Pharmacist

2021 ;46(10):14. According to the FDA's Center for Drug Evaluation and Research (CDER), 410 novel drugs have been approved over the past decade, ...

#18. Takeda's EXKIVITY™ (mobocertinib) Approved by U.S. FDA ...

... Approved by U.S. FDA as the First Oral Therapy Specifically Designed for Patients with EGFR Exon20 Insertion+ NSCLC. September 14, 2021. Approval based ...

#19. FDA Approved Drugs | CenterWatch

FDA Approved Drugs · Abcema (idecabtagene vicleucel) · Abilify (aripiprazole) · Abraxane (paclitaxel protein-bound particles for injectable suspension) · Abstral ( ...

#20. FDA shows jump in competitive generic approvals | RAPS

FDA approved 29 priority ANDAs in FY 2021, one more than the 28 approved in FY 2020. There was an increase of about 8% in the number of ...

#21. FDA-Approved HIV Medicines | NIH - HIVinfo

This table lists FDA approved HIV medicines recommended in HHS HIV/AIDS Guidelines. Click on a drug name to see ... Last Reviewed: August 24, 2021.

#22. FDA NEWS: June 30, 2021, and July 26, 2021 - The Oncology ...

FDA Approves Rezurock for the Treatment of Chronic Graft-versus- ...

#23. Revisiting FDA Approval of Aducanumab | NEJM

Revisiting FDA Approval of Aducanumab Given the scientific, regulatory, and clinical implications of the ... N Engl J Med 2021; 385:769-771

#24. 5 FDA approval decisions to watch in the fourth quarter

5 FDA approval decisions to watch in the fourth quarter. Published Oct. 1, 2021. By. Ben Fidler ,. Jonathan Gardner ,. Jacob Bell ,. Ned Pagliarulo ,.

#25. The FDA: 2021 activities at a glance - The Pharma Letter

The year 2021 saw the US Food and Drug Administration approval of 46 novel drugs, 1 80 first generics, 2 two biosimilars, 3 and nine novel ...

#26. Regulatory and clinical consequences of negative ... - The BMJ

On 27-29 April 2021, the FDA held a meeting of the Oncology Drug Advisory Committee (ODAC) to discuss six of the accelerated approvals that ...

#27. European Medicines Agency | - European Union

EMA Management Board: highlights of December 2021 meeting ... committee (CHMP) recommended thirteen medicines for approval at its December 2021 meeting.

#28. FDA Approves “Glowing Tumor” Imaging Drug to Better ...

The U.S. Food and Drug Administration (FDA) today approved an imaging drug known as Cytalux (pafolacianine), which is attracted to ... November 30, 2021.

#29. Welcome to the Ministry of Food and Drug Safety

MFDS warns cosumers against buying medicine online 2021-11-03; Administrative notice for the proposed amendment of Food Standards and Specifications]Press ...

#30. US FDA's Novel Approval Count Hits 32 In First Half Of 2021 ...

The FDA's Center for Drug Evaluation and Research cleared 27 new molecular entity and novel biologic approvals in the first six months of 2021 – ...

#31. US FDA approves Jardiance® (empagliflozin) to treat adults ...

Ridgefield, Conn. and Indianapolis, August 18, 2021 – Jardiance ... Today's FDA approval of Jardiance in heart failure with reduced ejection fraction, ...

#32. Pharmaceuticals and Medical Devices Agency - PMDA

December 14, 2021English translation of review report: Gore Viabahn Stent Graft; SHINSA December 14, 2021List of Approved Products (Medical Devices): FY2021 ...

#33. FDA Updates for Week of November 1, 2021 - Managed ...

In COVID-19 news, Merck receives UK authorization for oral antiviral, its first approval, and the FDA rejects EUA for COVID-19 respiratory ...

#34. fda 2021 | New Drug Approvals

New Drug Approvals · Posted in fda 2021 · Maribavir · FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs.

#35. FDA approvals in lung cancer treatment

September 2021. FDA has approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer with EGFR ...

#36. The FDA's Approval Of Aduhelm: Potential Implications Across ...

June 10, 2021 Doi: 10.1377/hblog20210609.921363 ... In this post, I explain the FDA's approval decision and explore its implications for both FDA approval ...

#37. Biotech Stocks Facing FDA Decision In October 2021 | Nasdaq

The first artificial intelligence (AI)-based digital pathology product to receive FDA approval, Paige Prostate that can help identify ...

#38. FDA Approves LUMAKRAS™ (Sotorasib), The First And Only ...

THOUSAND OAKS, Calif. , May 28, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved ...

#39. Sacituzumab Earns Regular FDA Approval for TNBC

Sacituzumab Govitecan Earns Full Approval for Triple-Negative Breast Cancer. Subscribe. May 12, 2021 , by NCI Staff. Illustration of a breast cancer tumor ...

#40. Press Releases | Friday, Oct 22, 2021 - Genentech

Lucentis is FDA-approved for the treatment of patients with wet age-related macular degeneration (AMD), macular edema following retinal vein ...

#41. 117th Congress (2021-2022): FDA Modernization Act of 2021

Summary of H.R.2565 - 117th Congress (2021-2022): FDA Modernization Act of 2021. ... This bill allows an applicant for market approval for a new drug to use ...

#42. An Overview of Oncology FDA Approvals: Summer 2021

An Overview of Oncology FDA Approvals: Summer 2021 · Keytruda plus chemotherapy for triple-negative breast cancer. · Darzalex Faspro for myeloma.

#43. 28 Digital Health Products Received FDA Approval in the First ...

The digital health companies focused on Clinical Decision Support software received 8 FDA approvals during 1H 2021. Mobile Wireless and Wearable Sensors ...

#44. BioMarin Receives FDA Approval for VOXZOGO™ (vosoritide ...

19, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has ...

#45. A Look Back at the FDA News from August 2021 - Targeted ...

In August 2021, the FDA granted 2 approvals for the treatment of renal cell carcinoma. Other cancer types that received FDA approved ...

#46. US FDA approves Roche's Tecentriq as adjuvant treatment for ...

Basel, 15 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® ...

#47. FDA to Prioritize Full Approval for Pfizer COVID Vaccine

FRIDAY, July 16, 2021 (HealthDay News) -- Pfizer Inc. announced on Friday that the U.S. Food and Drug Administration has granted priority review ...

#48. FDA Approves Updated Indication for Merck's KEYTRUDA ...

August 31, 2021 4:05 pm ET. KEYTRUDA Approved for Treatment of Patients With Locally Advanced or Metastatic Urothelial Carcinoma Who Are Not Eligible for ...

#49. New Drug Approvals on Track at FDA - PharmTech

In the first half of 2021, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) gave ...

#50. FDA Approves Trodelvy®, the First Treatment for Metastatic ...

Prior to the FDA approval of Trodelvy, patients with previously treated metastatic TNBC had few treatment options in this high unmet-need ...

#51. FDA Watch: October 2021 | Everyday Health

The latest news on U.S. Food and Drug Administration updates, recalls, approvals, and more.

#52. Will controversy over Alzheimer's drug doom the FDA faster ...

Just as the accelerated approval program is reaching peak ... drug spell the end for the FDA's faster approval process? ... 10, 2021.

#53. FDA Approves New Drug Against Weaponized Smallpox

June 10, 2021 -- The FDA has approved a new drug to treat smallpox. Fearful of a possible ... After this, the pharmaceutical company seeks FDA approval.

#54. 5 things to know about the FDA approval process - MD ...

The FDA may also approve cancer drugs before a Phase III clinical trial is done. This process is called accelerated approval. “We've seen ...

#55. Approval and launch dates for US biosimilars – 2021 - GaBI ...

To date (7 May 2021), the US Food and Drug Administration (FDA) has approved 29 biosimilars, plus four follow-on biologicals [1].

#56. What changes with approval of Pfizer's COVID-19 vaccine?

The FDA has fully approved the first COVID-19 vaccine, ... 24, 2021 ... that the Pfizer COVID-19 vaccine has been granted full FDA approval, ...

#57. FDA's Approval of Biogen's New Alzheimer's Drug Has Huge ...

With FDA approval in hand, attention now turns to decision-makers at the ... According to our estimates, in 2021, nearly 90% of Medicare ...

#58. FDA Aims for Full Approval of Pfizer Covid Vaccine on Monday

21, 2021, Section A, Page 11 of the New York edition with the headline: Pfizer's Two-Dose Vaccine Nears Full Approval by F.D.A..

#59. Recent FDA Approvals in Breast Cancer - The ASCO Post

On October 12, 2021, the FDA approved abemaciclib (Verzenio) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant ...

#60. April FDA Approvals to Watch - Dermatology Times

Explore the dermatologic drugs the FDA will make a decision to approve during April 2021. The FDA plans on making a decision on whether to ...

#61. FDA approves first new Alzheimer's drug in almost 20 years

Mon 7 Jun 2021 11.55 EDT ... The US Food and Drug Administration (FDA) has now approved the drug, but only on condition that those given it ...

#62. Pfizer plans to file for full FDA approval of Covid vaccine at the ...

Pfizer plans to file for full FDA approval of Covid vaccine at the end of this month. Published Tue, May 4 20216:53 AM EDT Updated Tue, May 4 202111:07 AM ...

#63. FDA Action Update, September 2021: Approvals, Submissions ...

The FDA made several actions in September 2021, including granting approvals and accepting applications for novel therapies across a variety ...

#64. FDA expands approval of Dupixent ® (dupilumab) to include ...

– October 20, 2021 - The U.S. Food and Drug Administration (FDA) has approved Dupixent ® (dupilumab) as an add-on maintenance treatment of ...

#65. Will CMS Find Aducanumab Reasonable and Necessary for ...

2021 ;326(5):383-384. doi:10.1001/jama.2021.11768 ... The recent US Food and Drug Administration (FDA) approval of aducanumab for the ...

#66. FDA Approval - Process of Approving Drugs & Medical Devices

A pharmaceutical company seeking FDA approval to sell a new prescription drug must complete a five-step process: discovery/concept, preclinical research, ...

#67. FDA gives its nod to 53 new drugs in 2020 - C&EN

January 4, 2021 | A version of this story appeared in Volume 99, Issue 2 ... In 2020, the FDA approved 53 new drugs, a healthy crop that arrived despite the ...

#68. Tezepelumab regulatory submission accepted and granted ...

The FDA grants Priority Review to applications for medicines that offer ... published in The New England Journal of Medicine in May 2021.

#69. FDA Approval Updates: Pfizer, Moderna, and J&J COVID-19

Pfizer requests full approval for COVID-19 vaccine in people ages 12 and older; CDC updates J&J vaccine recommendations. December 17, 2021. Pfizer requests to ...

#70. Full FDA Approval of a COVID-19 Vaccine: What You Should ...

The Pfizer/BioNTech COVID-19 vaccine received full approval by the FDA on Aug. 23, 2021. Lisa Maragakis, M.D., M.P.H., senior director of infection ...

#71. FDA Approval Summary: Osimertinib for Adjuvant Treatment of ...

On December 18, 2020, the FDA approved osimertinib as adjuvant therapy in patients with non–small cell lung cancer (NSCLC) whose tumors have ...

#72. What full FDA approval this fall means for COVID vaccines ...

July 22, 2021 11:00 AM PDT ... "Full FDA approval could kind of nudge some of those people who are currently unvaccinated and in that 'wait ...

#73. FDA approves pioneering drug for ovarian cancer surgery

Ovarian cancer patient Carol Giandonato admits to being apprehensive when her oncologist told her he wanted to make her cancer cells turn ...

#74. Full FDA approval of Covid-19 vaccines could help fight ... - CNN

Full FDA approval of Covid-19 vaccines could help fight vaccine hesitancy, ... Updated 11:50 AM ET, Fri April 30, 2021 ... The road to FDA approval.

#75. New Drug Approvals by FDA and EMA - Mid-2021 Recap

View New Drug Approvals by June 2021 with Estimated Sales (Free Excel Available) FDA's controversial approval of Biogen's Alzheimer's drug ...

#76. Q&A: When might the coronavirus vaccines get full approval?

The FDA's top vaccine official vowed to complete the process 'as rapidly as possible,' but would not ... August 2, 2021 at 9:00 a.m. EDT.

#77. Expected FDA Approvals for 2021 Include Drugs for Alzheimer ...

These new approvals could include aducanumab for Alzheimer disease, pegcetacoplan for the rare disease PNH, and 3 drugs for patients with ...

#78. Issues facing the FDA in 2021 | The Bayne Law Group, LLC

A new presidential administration and administrator may impact the Food and Drug Administration and its approval of drugs and medications.

#79. Pfizer's full FDA approval could lead to even greater profits

Moderna's total product revenue from its COVID-19 vaccine was $4.2 billion in the second quarter of 2021, and $5.9 billion for the first half of ...

#80. FDA approval of belzutifan culminates 25-year journey at ...

21, 2021 – A first-in-kind kidney cancer drug developed from laboratory and translational studies conducted at UT Southwestern Medical Center ...

#81. Biotech Stocks Facing FDA Decision In November 2021

On October 8, the FDA approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder.

#82. Controversial drug approval stokes concern about lack of a ...

Acting FDA commissioner Janet Woodcock appeared to distance herself from Monday's decision, despite a ... Updated: 06/11/2021 03:50 PM EDT.

#83. 3 Experts Quit An FDA Panel Over Alzheimer's Drug Approval

In his resignation letter, Dr. Aaron Kesselheim calls it "probably the worst drug approval decision in recent U.S. history." An FDA official ...

#84. New Drug Approvals On Track at FDA - Pharmaceutical ...

In the first half of 2021, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) gave ...

#85. What's the Difference Between Vaccine Approval (BLA)

A Biologics License Application, or BLA, is FDA's standard “full approval” mechanism for ... where it originally appeared on June 3, 2021.

#86. Pfizer and BioNTech Initiate Rolling Submission of Biologics ...

... of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA ... Friday, May 07, 2021 - 06:45am.

#87. Zealand Pharma Announces FDA Approval of Zegalogue®

Company announcement – No. 16 / 2021 Zealand Pharma Announces FDA Approval of Zegalogue® (dasiglucagon) injection, for the Treatment of ...

#88. What Full FDA Approval of the COVID-19 Vaccines Will Mean

Vaccine mandates and population hesitancy could be affected. by Sarah Elizabeth Adler, AARP, Updated July 16, 2021. photo illustration a medical syringe and ...

#89. FDA Approved Drugs: January 2021 | Express Scripts

Xolair Receives Additional FDA Approval The FDA approved Genentech's monoclonal antibody, Xolair® (omalizumab), for a third indication on ...

#90. FDA Accepts REGEN-COV® (casirivimab and imdevimab) for ...

TARRYTOWN, N.Y. , Oct. 14, 2021 /PRNewswire/ -- Regeneron Pharmaceuticals, ... In the U.S. , REGEN-COV has not been approved by the FDA, ...

#91. Why hasn't the FDA given COVID-19 vaccine full approval yet?

WASHINGTON, D.C. — The United States started 2021 with a race to expand the reach of the COVID-19 vaccine.

#92. End of Year Wrap Up: Key Updates in Myeloma in 2021 and ...

Presented at 2021 American Society of Hematology Annual Meeting and Exposition; December 11-14, 2021; Atlanta, GA. Abstract 3866. FDA approves ...

#93. 2 Upcoming FDA Approval Decisions That Investors Should ...

The FDA is scheduled to announce these two key approval decisions in late November. ... Oct 23, 2021 at 6:01AM. Author Bio. Keith began writing for the Fool ...

#94. 2021 Was an "Inflection Year" for Biosimilars

In July 2021, the FDA also approved another drug as a biosimilar and an interchangeable (Semglee, insulin glargine), but this drug was ...

#95. 00449 | Health Alert Network (HAN) - CDC Emergency ...

August 26, 2021, 11:40 AM ET CDCHAN-00449. Summary Ivermectin is a U.S. Food and Drug Administration (FDA)-approved prescription medication used to treat ...

#96. FDA Meets All Goal Dates for 2020 Drug Approvals - Policy ...

CME/CNE/CPE Medical Education Program Helps Physicians… Nov 6, 2021. In 2020, more than half (31 of 53, or 58%) ...