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Approvals

FDA approved Ascendis Pharma’s Skytrofa.
FDA
Report: NDA, BLA Approvals by the FDA Fell 16% in 2019
A new report released on Tuesday by GlobalData suggested that there was a 16% decrease in new drug approvals (NDAs) by the U.S. Food and Drug Administration last year.
May 12, 2020
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2 min read
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Krystle Vermes
Drug Development
Biopharma Update on the Novel Coronavirus: May 12
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 12, 2020.
May 12, 2020
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3 min read
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BioSpace Editorial Staff
FDA
Abbott Earns Emergency Use Authorization for Another COVID-19 Antibody Test
Approval of Abbott’s latest antibody test comes days after the FDA tightened its rules regarding the regulatory requirement for them.
May 11, 2020
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2 min read
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Alex Keown
TARPEYO is the first FDA-approved drug for immunog
FDA
AstraZeneca and Merck’s Lynparza Approved For Ovarian Cancer Just a Week After GSK’s Zejula
The Lynparza approval isn’t as broad as the Zejula approval, with Lynparza not approved for use in patients with homologous recombination deficiencies.
May 11, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 11
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 11, 2020.
May 11, 2020
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4 min read
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BioSpace Editorial Staff
Jonathan Weiss/Shutterstock
FDA
FDA Approves Eli Lilly’s Precision Oncology Treatment Retevmo for Certain Lung and Thyroid Cancers
Eli Lilly is moving quickly to get a newly-approved precision oncology treatment, Retevmo, for certain lung and thyroid cancers into the hands of patients.
May 11, 2020
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3 min read
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Alex Keown
FDA
FDA Grants Emergency Use Authorization for Rutgers’ At-Home COVID-19 Saliva Test
The new at-home saliva self-collection assay allows for broader screening than the standard and uncomfortable method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
May 8, 2020
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2 min read
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Alex Keown
FDA
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here’s a look at what’s on the schedule for the next two weeks.
May 8, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: May 8
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 8, 2020.
May 8, 2020
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5 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 7
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 7, 2020.
May 7, 2020
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5 min read
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BioSpace Editorial Staff
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PRESS RELEASES
FDA
FDA Approves First Generic of Restasis
February 2, 2022
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3 min read
FDA
Theseus Pharmaceuticals Receives U.S. FDA Orphan Drug Designation for THE-630 for the Treatment of Advanced Gastrointestinal Stromal Tumors (GIST)
February 2, 2022
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4 min read
FDA
U.S. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Only Long-Acting HIV Treatment
February 1, 2022
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14 min read
FDA
FDA Approves SPIKEVAX®, Moderna’s mRNA COVID-19 Vaccine
February 1, 2022
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2 min read
FDA
ViiV Healthcare Announces US FDA Approval of Cabenuva (cabotegravir, rilpivirine) for Use Every Two Months, Expanding the Label of the First and Only Complete Long-Acting HIV Treatment
February 1, 2022
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15 min read
FDA
PharmaTher Granted FDA Orphan Drug Designation for Ketamine to Treat Status EpilepticusThird FDA orphan drug designation for ketamine granted to PharmaTher
February 1, 2022
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4 min read
Drug Development
Denovo Biopharma LLC Announces FDA Approval of IND to Initiate First Biomarker-Guided Global CNS Clinical Trial for Treatment-Resistant Depression (TRD)
January 31, 2022
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2 min read
FDA
Moderna Receives Full U.S. FDA Approval for COVID-19 Vaccine Spikevax
January 31, 2022
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6 min read
FDA
Immune-Onc Therapeutics Announces FDA Clearance of IND Application to Initiate Trial of IO-202, a First-in-Class Myeloid Checkpoint Inhibitor Targeting LILRB4, in Patients with Advanced Solid Tumors
January 31, 2022
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5 min read
FDA
Fifth Eye Receives FDA Clearance to Market AHI System™
January 31, 2022
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3 min read
FDA
U.S. FDA Approves New Label Update for CAR T-Cell Therapy Yescarta® Showing Prophylactic Steriod Use Improves Management of Cytokine Release Syndrome
January 31, 2022
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17 min read
FDA
FDA Approves Prophylactic Treatment with VONVENDI® [von Willebrand Factor (Recombinant)] for Adult Patients Living with Severe Type 3 von Willebrand Disease (VWD)
January 31, 2022
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11 min read
FDA
Spectral Medical Announces U.S. FDA Approval of DIMI Trial Protocol AmendmentAmendment expected to overcome key pandemic challenges and improve both site and patient enrollment
January 31, 2022
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4 min read
FDA
FDA Approves Genentech’s Vabysmo, the First Bispecific Antibody for the Eye, to Treat Two Leading Causes of Vision Loss
January 28, 2022
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13 min read
Press Releases
Catalyst Pharmaceuticals Announces Issuance of Mandate by the U.S. Court of Appeals for the 11th Circuit Directing the District Court Judge in Catalyst’s Lawsuit Against the FDA to Grant Summary Judgement in Favor of Catalyst
January 28, 2022
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2 min read
FDA
B. Braun Receives FDA Approval of Daytona Beach Pharmaceutical Manufacturing Site
January 28, 2022
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2 min read
FDA
ALX Oncology Receives U.S. FDA Orphan Drug Designation for Evorpacept for the Treatment of Patients with Gastric Cancer and Gastroesophageal Junction Cancer
January 27, 2022
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4 min read
FDA
FDA Grants Breakthrough Therapy Designation for Dizal Pharmaceutical’s DZD9008 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon20 Insertion
January 27, 2022
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3 min read
FDA
Melanoma Research Alliance Statement on FDA Approval of Tebentafusp, the First Drug for Treating Metastatic Uveal Melanoma
January 26, 2022
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1 min read
FDA
Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
January 26, 2022
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29 min read
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