FDA Archives - Page 89 of 220

2 minute read

Administration’s Abortion Drug Battle: White House to Contest Texas Ruling on Approval Suspension

April 10, 10:33 AM

On Friday, U.S. District Judge Matthew Kacsmaryk in Amarillo, Texas, suspended the approval of mifepristone, making the sale of the abortion pill illegal in the U.S.

CVS

2 minute read

Vertex Announces Health Canada Market Authorization For ORKAMBI In Children With Cystic Fibrosis Ages 1 To <2 Years

By Happy Mohamed

April 10, 10:18 AM

- With this approval, approximately 30 children with two copies of the F508del mutation are eligible for a medicine that treats the underlying cause of their disease for the first time - TORONTO, April 10,

VRTX

1 minute read

Sarepta Therapeutics Announces That The Date Of The Advisory Committee Meeting For SRP-9001 Will Be May 12, 2023

By Happy Mohamed

April 10, 9:38 AM

Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced that the date of the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies

SRPT

1 minute read

Trouble Persists For Philips: Most Serious FDA Recall Label Hits Reworked Respiratory Devices

By Vandana Singh

April 10, 9:18 AM

Koninklijke Philips NV (NYSE PHG) has recalled certain reworked DreamStations respiratory devices because some devices were assigned incorrect or duplicate serial…

PHG

2 minute read

ABVC BioPharma Provides ABV-1601 Update On Phase I Site Initiation Visit Conducted At Cedars-Sinai Medical Center

By Happy Mohamed

April 10, 8:31 AM

ABVC BioPharma, Inc. (NASDAQ:ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that the Phase 1 Site Initiation Visit

ABVC

3 minute read

Reported Late Thursday April 6, MRNA Cancer Vaccine MRNA-4157/V940 In Combination With Keytruda, Receives Prime Scheme Designation From the European Medicines Agency For Adjuvant Treatment Of Patients With High-Risk Stage III/IV Melanoma

By Happy Mohamed

April 7, 1:07 AM

Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma CAMBRIDGE, MA and RAHWAY, NJ / ACCESSWIRE / April 6, 2023

MRK

1 minute read

FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits

By Vandana Singh

April 6, 1:45 PM

Today, the FDA announced the final decision to withdraw approval of Privately held-Covis Pharma’s Makena (hydroxyprogesterone caproate injection), a drug approved…

BBH

2 minute read

JNJ Rybrevant Receives Canadian Agency For Drugs and Technologies In Health Reimbursement Recommendation For The Treatment Of Adult Patients With Non-Small Cell Lung Cancer With Activating EGFR Exon 20 Insertion Mutations

By Happy Mohamed

April 6, 12:43 PM

Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the Canadian Agency for Medicines and Health Technologies ( ACMTS ) recommended that RYBREVANT® ( amivantamab ) be reimbursed by public schemes for the treatment of adult patients with non-small cell lung cancer ( CPNPC ) locally advanced or metastatic, carriers of activating mutations for the insertion of exon 20 of the e

JNJ

2 minute read

GeoVax Announces Presentation Of Preliminary Data From Clinical Trial Of Next-Generation COVID-19 Vaccine Candidate

By Happy Mohamed

April 6, 10:02 AM

Analysis of Open-Label Portion of Ongoing Phase 2 Trial of GEO-CM04S1 Presented at 23rd Annual World Vaccine Congress Atlanta, GA, April 06, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire – GeoVax

GOVX