Shilpa’s Unit-2 passes second consecutive FDA inspection
Shilpa Medicare announces that Shilpa Pharma Lifesciences – a wholly owned subsidiary – has successfully passed a U.S. Food and Drug Administration (FDA) inspection for its Unit-2 facility in Raichur,...
View ArticleFDA expands Pfizer RSV vaccine to all high-risk adults
The FDA has expanded approval for Pfizer’s respiratory syncytial virus (RSV) vaccine, Abrysvo, to include adults aged 18–59 years who are at higher risk of lower respiratory tract disease from the...
View ArticleSirnaomics announces completion of IND-Enabling studies of safety and...
Sirnaomics, a leading biopharmaceutical company engaging in the discovery and development of advanced RNAi therapeutics, announced today that it has completed IND-enabling studies for STP125G.
View ArticleGeron Announces FDA Approval of RYTELO
Geron Corporation announced that the U.S. FDA has approved RYTELO (imetelstat) for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes.
View ArticleUS FDA Approves Expanded Age Indication For GSK’s Arexvy
GSK have announced that the US Food and Drug Administration has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD)...
View ArticleNovartis Radioligand Therapy Lutathera FDA Approved
Novartis have announced that the FDA have approved Lutathera for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine...
View ArticleAlvotech Signs U.S. Agreement
Alvotech announced a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration approved...
View ArticleFDA Approve Takeda's Crohn's Disease Therapy
Takeda have announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely...
View ArticleGSK's Meningococcal Vaccine Approved for Regulatory Review
GSK have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate.
View ArticleSK Life Science XCOPRI CV Receives FDA Approval
SK Life Science, a subsidiary of SK Biopharmaceuticals, have announced that the U.S. Food and Drug Administration approved two new administration options of XCOPRI (cenobamate tablets) CV, an...
View ArticleOrchard Therapeutics Receives FDA Approval of Lenmeldy
Orchard Therapeutics, recently acquired by Kyowa Kirin, have announced the U.S. FDA has approved Lenmeldy for the treatment of children with early-onset—metachromatic leukodystrophy.
View ArticleMadrigal Pharmaceuticals announces FDA approval of Rezdiffra
Madrigal Pharmaceuticals have announced that the U.S. FDA has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic...
View ArticleWegovy Approved in the US for Cardiovascular Risk Reduction
Novo Nordisk have announced that the US FDA has approved a label expansion for Wegovy for the indication of reducing risks of major adverse cardiovascular events.
View ArticleAgepha Pharma and Caristo Diagnostics Team Up to Fight Coronary Inflammation
Agepha Pharma together with Caristo Diagnostics have announced their collaboration to improve awareness and clinical education about the central role of inflammation in coronary artery disease.
View ArticleAbbVie Receive EMA and FDA Updates on Lymphoma Treatment
AbbVie have provided updates from the FDA and EMA for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular...
View ArticleImpact of Revisions to Good Manufacturing Practices Annex 1 on Sterile Drug...
The European Commission’s revision of its Good Manufacturing Practices (GMP) Annex 1 for sterile drug products will have implications for pharmaceutical companies that market their sterile drug...
View ArticleCarthera Signs Strategic Collaboration with Accord Healthcare
Carthera announces the signing of a strategic collaboration with Accord Healthcare Limited, a leading pharmaceutical company, for the supply of carboplatin. The financial terms of the agreement have...
View ArticleQuotient Sciences Announces Successful US FDA Inspection of UK Facility
Quotient Sciences announces the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.
View ArticleNovavax COVID-19 Vaccine Authorised In U.S.
Novavax, Inc recently announced that the Novavax COVID-19 Vaccine has received Emergency Use Authorisation from the U.S. FDA for active immunisation to prevent COVID-19 in individuals aged 12 and older.
View ArticlePhillips-Medisize Teams with GlucoModicum to Develop Needle-Free Continuous...
Phillips-Medisize has teamed with GlucoModicum to design and eventually commercialise a proprietary non-invasive, wearable device that removes technology and patient-care roadblocks to continuous...
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