Approvals
Stay up-to-date with the latest drug approvals by regulatory agencies worldwide. Gain insights into the regulatory processes, safety evaluations, and efficacy assessments. Stay informed about the new treatments available to patients and the impact they have on healthcare practices.
EC Approves Pfizerās Abrysvo, Only RSV vaccine in EU for adults and infants
Pfizer has just received approval from the European Commission (EC) for its groundbreaking vaccine, Abrysvo. This vaccine, targeting the respiratory ...
Pfizer’s Abrysvo Achieves Landmark as First Maternal RSV Vaccine to Safeguard Newborns
Pfizer’s Abrysvo has achieved a groundbreaking milestone by becoming the first vaccine to safeguard newborns against respiratory syncytial virus (RSV) ...
FDA Approves Ingrezza (valbenazine) Capsules to Treat Chorea in Huntingtonās Disease
Neurocrine Biosciences has achieved a significant milestone with the announcement of US Food and Drug Administration (FDA) approval for Ingrezza ...
Janssen’s Bispecific Antibody Tecvayli Receives European Commission Approval for Reduced Dosing Frequency
The Janssen Pharmaceutical Companies of Johnson & Johnson have proudly unveiled a significant advancement in cancer treatment. The European Commission ...
FDA Grants Landmark Approval to Veopoz for the Treatment of Pediatric and Adult CHAPLE Disease
On August 18, 2023, Regeneron Pharmaceuticals announced a remarkable milestone. The US Food and Drug Administration (FDA) has granted approval ...
FDA Approves Eylea HD Injection 8 mg for the Treatment of Wet Age-related Macular Degeneration, Diabetic Macular Edema, and Diabetic Retinopathy
On August 18, 2023, Regeneron Pharmaceuticals announced a groundbreaking development in the field of ophthalmology: the US Food and Drug ...
Forxiga Receives Green Light in China to Mitigate Cardiovascular Mortality and Hospitalization in Adults Battling Symptomatic Chronic Heart Failure
China’s National Medical Products Administration (NMPA) has granted approval to Forxiga (dapagliflozin) as a groundbreaking solution in the fight against ...
Aquipta Gets the Nod for Migraine Prevention in European Adults, courtesy of AbbVie
AbbVie has made a significant stride in the realm of migraine management with the European Commission’s green light for Aquipta ...
FDA Grants Approval to Ipsen’s Sohonos Capsules, the First-Ever Treatment for Individuals with Fibrodysplasia Ossificans Progressiva
In 2019, Ipsen made a significant investment of $1 billion to acquire Clementia Pharmaceuticals and its rare disease drug, palovarotene. ...
Delcath Triumphs After Years: FDA Grants Approval to Hepzato Kit for Treating Metastatic Uveal Melanoma
After enduring nearly a decade of setbacks, Delcath has finally achieved a regulatory milestone in the United States. Delaware-based Delcath ...
Revance into Therapeutic Realm with FDA Approval for Cervical Dystonia Treatment, Daxxify
Revance, a prominent player in the aesthetics market, has now made a strategic move into the promising therapeutic arena. Following ...
Pfizer’s Elrexfio Gets FDA Nod, Ignites Showdown with J&J in Multiple Myeloma Arena
Pfizer’s latest BCMA-targeted drug, Elrexfio (elranatamab), has gained FDA approval for treating multiple myeloma patients who have undergone at least ...
Johnson & Johnson Breaks Into Prostate Cancer Market with Akeega
After the FDA’s green light for AstraZeneca/Merck and Pfizer’s PARP inhibitors, Johnson & Johnson (J&J) has now secured its own ...
Johnson & Johnson Takes Lead in Bispecific Antibody Approval for Multiple Myeloma, Leaving Pfizer in the Dust
The FDA has granted accelerated approval to talquetamab-tgvs, branded as Talvey, for treating relapsed or refractory multiple myeloma in adults ...
Beyfortus: A Breakthrough RSV Shot for Infants Approved by CDC
Source – Sanofi The US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has given ...
FDA Approves Zurzuvae: A Game-Changer for Postpartum
Source – Biogen Biogen and Sage Therapeutics have received FDA approval for Zurzuvae (zuranolone) 50 mg, a breakthrough treatment for ...
FDA Approves Izervay for Geographic Atrophy
Source –Ā Astellas Pharma Astellas Pharma has received FDA approval for Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic ...
Merck’s Ervebo has received US FDA approval for use in children 12 months of age and older
Source – Merck Merck announced that the US Food and Drug Administration (FDA) has granted expanded approval for Ervebo. The ...
Endometrial Cancer Patients Get New Option with Jemperli
Source – GSK GSK has secured approval from the US for Jemperli, in combination with chemotherapy, as a first-line treatment ...
Lonsurf gets a boost from FDA for colorectal cancer, challenging rivals Takeda and Hutchmed
Source – Taiho OncologyĀ Eight years after initially gaining FDA approval for the treatment of heavily pretreated colorectal cancer, Taiho ...
Gilead’s Trodelvy for Pre-Treated HR+/HER2- Metastatic Breast Cancer Receives European Commission Approval
Source – Gilead Gilead Sciences, has received approval from the European Commission (EC) for the use of Trodelvy (sacituzumab govitecan) ...
Balfaxar, a warfarin reversal medication from Octapharma, receives FDA approval
Source – Octapharma More than 2.4 million individuals in the United States rely on warfarin, a blood thinner, to prevent ...
A New Hope for Children and Teens with gMG: Soliris Gets EU Approval
Source – AstraZeneca The European Union (EU) has granted approval for the expanded use of Soliris (eculizumab) to treat refractory ...
Jardiance Receives EU Approval for Treating Chronic Kidney Disease (CKD), Posing a Strong Challenge to Forxiga
Source – Boehringer Ingelheim The European Union has granted approval for Boehringer Ingelheim and Eli Lilly’s SGLT2 inhibitor, Jardiance (empagliflozin), ...
Tarsus’ Xdemvy is approved by the FDA as the first therapy for common eyelid illness
Source – Tarsus Pharmaceuticals Tarsus Pharmaceuticals has achieved a groundbreaking milestone with the FDA approval of Xdemvy, the first-ever treatment ...
FDA Greenlights Verrica Pharmaceuticals’ Ycanth (cantharidin) Topical Solution 0.7%
Source – Verrica Pharmaceuticals After facing two rejections from the FDA, both related to manufacturing issues, Verrica Pharmaceuticals has finally ...
FDA Grants Approval to Emergent’s Anthrax Vaccine Cyfendus After 4 Years of Supplying the Shot
Source – Emergent BioSolutons Emergent BioSolutions has been delivering its AV7909 anthrax vaccine to the Department of Health and Human ...
Elevar Therapeutics Announces FDA Acceptance of Rivoceranib-Camrelizumab Combo for Liver Cancer
On July 17, 2023Ā Elevar Therapeutics, a fully integrated biopharmaceutical company focused on improving treatment options for patients with limited ...
FDA has approved Beyfortus as a treatment for RSV illness in newborns
Source – Sanofi On July 17, 2023 Sanofi and AstraZeneca received approval from the US Food and Drug Administration (FDA) ...
Enhertu Receives Approval in China as Groundbreaking HER2-Directed Therapy for HER2-Low Metastatic Breast Cancer Patients
Source – AstraZenecaĀ Enhertu (trastuzumab deruxtecan), a targeted antibody drug conjugate developed by AstraZeneca and Daiichi Sankyo, has received approval ...
