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Latest Pharma News and Updates for BeiGene, Seagen, Alnylam, Roche, Astellas
BeiGene’s Brukinsa Approval; FDA Approval to Seagen’s TUKYSA; NICE Recommends Alnylam’s Amvuttra; FDA Approves Brenzavvy for Type 2 Diabetes; Roche’s Tecentriq to be Filed for Early-stage Liver Cancer; FDA Lifts Hold on Astellas’ Pompe Gene Therapy

FDA Approves BeiGene’s Brukinsa for CLL/SLL BeiGene's Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) has been approved by the US Food and Drug Administration. CLL is a common type of leukemia, accounting for approximately 25% of all new cases each year. SLL is...

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MedTech News for Cardiovascular Systems, Koneksa, Medcura, Abbott, Enovis, Bausch + Lomb, AcuFocus
First Patient Enrolled in Kaizen Clinical Study in Japan; Koneksa’s At-Home Mobile Spirometry Clinical Trial; Medcura’s LifeGel™ Absorbable Surgical Hemostat; FDA Clearance to Abbott’s NAVITOR; Enovis’s DynaClip Delta™ and DynaClip Quattro™ bone staples; Bausch + Lomb Acquired AcuFocus

First Patient Enrolled in Kaizen Clinical Study in Japan  On January 11, 2023, Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional treatment systems for patients suffering from peripheral and coronary artery disease, announced the initiation of the...

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Pharma News and Updates for AbbVie, Ferring, Merck, CSL, Amicus, Takeda
Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result

AbbVie Secures Fourth FDA Approval for Vraylar AbbVie has received its fourth FDA approval for Vraylar, adding major depressive disorder (MDD) adjunctive therapy to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. According to AbbVie, the approval makes Vraylar (cariprazi...

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Pharma News for AstraZeneca, Regeneron, Tenaya, Daiichi, C4X Discovery
C4X Discovery and AstraZeneca Signs Deal; FDA Rejects Spectrum’s Poziotinib; Orphan Drug Designation to Tenaya’s Gene Therapy; EC Approves Regeneron’s Libtayo; Response Letter to Poziotinib for Metastatic NSCLC Harboring HER2 Exon 20 Mutations; Japan Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer

C4X Discovery Holdings and AstraZeneca Signs Exclusive USD 402 Million Global License C4X Discovery Holdings has signed an exclusive global license with AstraZeneca worth up to USD 402 million for the development and commercialization of the NRF2 Activator program. The agreement will allow AstraZeneca to develop...

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Horizon-Arrowhead-deal-Dr-Reddy-Lab-Drug-US-Launch-Targovax-ONCOS-102;-RedHill-Oral-Opaganib-COVID-19
Horizon/ Arrowhead Deal; Dr Reddy’s Lab’s Drug US Launch; Targovax’s ONCOS-102; RedHill’s Oral Opaganib in COVID-19

Horizon Dishes Out Million Dollars to get Arrowhead's RNAi Drug Arrowhead Pharmaceuticals and Horizon Therapeutics have announced a research and development collaboration to advance the treatment landscape for uncontrolled gout. Under the terms and conditions, Arrowhead is bound to receive an upfront sum of U...

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Latest COVID News | Pharma Happenings
HCQ/ CQ failure; AZ/ Catalent’s deal; Sinovac’s CoronaVac and Lilly’s Olumiant trial results

The US FDA nullified the Emergency Use Authorization (EUA) granted to chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19. The regulatory authority had granted the EUA to malarial drugs to be used in hospitalized COVID-19 patients only when a clinical trial was unavailable, or participation in...

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Pharma News
AZ announces positive results for durvalumab and tremelimumab; FDA nods to extend LILETTA’s use to prevent pregnancy; Gilead, Glympse Bio teams up to advance NASH clinical development

AstraZeneca recently has announced the results of the clinical trials POSEIDON which included the study of a combination of drugs Imfinzi (durvalumab) and tremelimumab with chemotherapy in lung cancer. Imfinzi is a human monoclonal antibody which blocks the interaction of PD-L1 with PD-1 by binding itself with ...

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Pharma news
FDA approval to AZ’s Farxiga for heart failure; GSK divests two travel vaccines to Bavarian Nordic; New breakthrough therapy for Cystic Fibrosis

The US FDA today has given its nod to Trikafta (elexacaftor/ivacaftor/tezacaftor) of Vertex Pharmaceuticals, the first of its kind triple combination therapy for the patients with cystic fibrosis. The drug, Trikafta, has been approved for patients of age 12 years and older who have at least one F508del mutation...

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First oral GLP-1 treatment approved for type2 Diabetes

The US FDA has approved Rybelsus (semaglutide) oral tablets to improve blood sugar in adult patients with Type II Diabetes. Rybelsus is an oral glucagon-like peptide (GLP-1) receptor protein treatment which has been approved after 15 years of the approval first GLP-1 agonist. GLP-1 is a hormone found in insuffi...

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Peanut allergy
FDA is reviewing a dangerous way to treat Peanut Allergy

Peanut allergies (PA) are the most common and severe type of food allergies in children. Even a small fragment of this legume to an allergic person can result in permanent brain damage.  The prevalence rate of the Peanut allergy, over the past two decades, has tripled. According to DelveInsight, total prevalen...

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