Latest news with #Approval
Business Standard
16-07-2025
- Business
- Business Standard
Zydus' Matoda facility completes Remote Regulatory Assessment of USFDA
Zydus Lifesciences announced that the USFDA conducted a Remote Regulatory Assessment (RRA) at Zydus' formulations manufacturing facility at Matoda in Gujarat for the Prior Approval Supplement (PAS) of Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg and 80 mg. At the closure, there were no observations noted, and the site was recommended for approval.
7NEWS
10-07-2025
- Entertainment
- 7NEWS
Julian McMahon's exact cause of death revealed
Julian McMahon's cause of death has been confirmed. The Nip/Tuck actor passed away last week aged 56 after a battle with cancer and documents obtained by People have revealed that he died from lung metastasis as a result of head and neck metastatic cancer. A Cremation Approval Summary Report from Pinellas County Medical Examiner's Office in Florida ruled the manner of McMahon's death as natural and his remains have since been cremated. McMahon's wife Kelly Paniagua shared the tragic news that the Australian star had passed away last week. She said in a statement: 'With an open heart, I wish to share with the world that my beloved husband, Julian McMahon, died peacefully this week after a valiant effort to overcome cancer. 'Julian loved life. He loved his family. He loved his friends. He loved his work, and he loved his fans. His deepest wish was to bring joy into as many lives as possible. 'We ask for support during this time to allow our family to grieve in privacy. And we wish for all those to whom Julian brought joy, to continue to find joy in life. We are grateful for the memories.' A post was shared on McMahon'sInstagram page earlier this week thanking the Charmed star's fans for the love and support they have shown since his passing. The post featured Van Morrison's track Sometimes We Cry, which is thought to have been one of McMahon's favourite songs. A black and white image of the star was captioned: 'Julian loved @vanmorrisonofficial... For all those who loved Julian, thank you.' Tributes poured in for Julian across the industry following his death and his former Charmed co-star Alyssa Milano said she felt 'heartbroken' after hearing the news. The 52-year-old star wrote on Instagram: 'I'm heartbroken. 'Julian McMahon was magic. That smile. That laugh. That talent. That presence. He walked into a room and lit it up - not just with charisma, but with kindness. With mischief. With soulful understanding. 'We spent years together on Charmed - years of scenes, stories, and so many in-between moments. He made me feel safe as an actor. Seen as a woman. He challenged me, teased me, supported me. We were so different, and yet somehow we always understood each other.' Alyssa remembered Julian - who leaves behind daughter Madison, 25, from his relationship with ex-wife Brooke Burns - as a 'dear friend' and offered her condolences to his loved ones. The post continued: 'Julian was more than my TV husband. He was a dear friend. The kind who checks in. The kind who remembers. The kind who shares. The kind who tells you the truth, even when it's uncomfortable - but always with love. 'My heart is with Kelly, with Madison, and with Iliana - his girls, his world. He adored them. You could feel it in every conversation, every story, every text. He was a family man above all, and he loved deeply. 'Losing him feels unreal. Too soon. Too unfair.'
Perth Now
10-07-2025
- Entertainment
- Perth Now
Julian McMahon's cause of death revealed
Julian McMahon's cause of death has been confirmed. The Nip/Tuck actor passed away last week aged 56 after a battle with cancer and documents obtained by People have revealed that he died from lung metastasis as a result of head and neck metastatic cancer. A Cremation Approval Summary Report from Pinellas County Medical Examiner's Office in Florida ruled the manner of McMahon's death as natural and his remains have since been cremated. Julian's wife Kelly Paniagua shared the tragic news that the Australian star had passed away last week. She said in a statement: "With an open heart, I wish to share with the world that my beloved husband, Julian McMahon, died peacefully this week after a valiant effort to overcome cancer. "Julian loved life. He loved his family. He loved his friends. He loved his work, and he loved his fans. His deepest wish was to bring joy into as many lives as possible. "We ask for support during this time to allow our family to grieve in privacy. And we wish for all those to whom Julian brought joy, to continue to find joy in life. We are grateful for the memories." A post was shared on Julian's Instagram page earlier this week thanking the Charmed star's fans for the love and support they have shown since his passing. The post featured Van Morrison's track Sometimes We Cry, which is thought to have been one of McMahon's favourite songs. A black and white image of the star was captioned: "Julian loved @vanmorrisonofficial... For all those who loved Julian, thank you." Tributes poured in for Julian across the industry following his death and his former Charmed co-star Alyssa Milano said she felt "heartbroken" after hearing the news. The 52-year-old star wrote on Instagram: "I'm heartbroken. "Julian McMahon was magic. That smile. That laugh. That talent. That presence. He walked into a room and lit it up - not just with charisma, but with kindness. With mischief. With soulful understanding. "We spent years together on Charmed - years of scenes, stories, and so many in-between moments. He made me feel safe as an actor. Seen as a woman. He challenged me, teased me, supported me. We were so different, and yet somehow we always understood each other." Alyssa remembered Julian - who leaves behind daughter Madison, 25, from his relationship with ex-wife Brooke Burns - as a "dear friend" and offered her condolences to his loved ones. The post continued: "Julian was more than my TV husband. He was a dear friend. The kind who checks in. The kind who remembers. The kind who shares. The kind who tells you the truth, even when it's uncomfortable - but always with love. "My heart is with Kelly, with Madison, and with Iliana - his girls, his world. He adored them. You could feel it in every conversation, every story, every text. He was a family man above all, and he loved deeply. "Losing him feels unreal. Too soon. Too unfair."
Telegraph
13-06-2025
- Climate
- Telegraph
Horse racing tips: Friday, June 13
Our resident horse racing tipster Ron Wood continues to unearth the winners and has a tip at Sandown this afternoon, as well as a NAP selection at Goodwood in the evening. Ron Wood's selections: Odds provided by William Hill and correct at the time of writing. Stars denote strength of selection (max 5). If you already have a William Hill account and are looking for a new bookmaker to use for this week's racing, check out more free bets from the best betting sites, reviewed by our experts. 3.15 Sandown – Class 3 Handicap (1m 2f) APPROVAL has disappointed on both starts this year but he has a tendency to go right in his races, so Redcar, a left-handed track, didn't suit him last time out. He won a decent handicap over this trip at Goodwood last summer, edging out Brioni, who he now meets on 5lb better terms, and this is the selection's first start on a right-handed track since then. Approval is also dropping down from Class 2, sneaking into this contest off joint-top weight. It's Royal Ascot next week. Find the best Royal Ascot free bets and betting offers 7.50 Goodwood - Class 4 Handicap (5f) WHEELS OF FIRE (NAP) is all speed, so this drop back to the minimum distance on a sharp track is good for him. He was well beaten at Ascot last time but that was over a stiff 6f and he was just about the last to come under pressure before fading. On his outing before that, he was second to a big improver who went on to win a decent handicap at Chester next time. Wheels Of Fire won a novice on the Lingfield all-weather, which is also a sharp test, on his only previous race over 5f. Selection: Wheels Of Fire @ 5/2 with William Hill Go to site > Today's racing (Flat unless stated) Sandown 1.00-5.00 Chester 1.40-5.10 York 1.50-5.20 Cork 4.52-8.15 Fairyhouse 5.05-8.30 Newton Abbot (NH) 5.35-9.00 Goodwood 5.30-8.20 Market Rasen (NH) 5.50-8.45 Ron Wood 2025 horse racing P/L (up to and including Thursday June 12) Star ratings explained ⭐⭐⭐⭐⭐ - confident selection ⭐⭐⭐⭐ - strong fancy ⭐⭐⭐ - fair claims ⭐⭐ - tentative choice ⭐ - minimum confidence If you want to find more odds and offers, take a look at our list of the best betting sites and free bets Check out our list of the best casino bonuses in the UK
Associated Press
20-05-2025
- Business
- Associated Press
The FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: June 11-12, 2025)
DUBLIN--(BUSINESS WIRE)--May 20, 2025-- The 'The FDA (Food and Drug Administration) Drug Approval Process Training Course' training has been added to offering. This programme will be especially beneficial to those responsible for preparing US registration documents (INDs,NDAs, Biologics License Applications, etc), regulatory affairs personnel, lawyers and others responsible for advising companies on strategies for developing new drugs for the US market. The US is the largest market globally for pharmaceutical sales, so having a good understanding of FDA procedures is vital for those submitting in this challenging region. This course will help clarify the US regulatory process, giving you a practical insight into FDA requirements and ensuring that you are fully up to date with all the latest developments. The comprehensive programme will cover procedures for submission of INDs, NDAs, ANDAs and 505(b)(2), provide a useful insight into the organisation and structure of the FDA and its review processes, and highlight recent changes. The course will emphasise areas of interest to innovative manufacturers, but will also deal with issues relating to generic and over-the-counter drugs. There will be ample opportunity for discussion with our expert trainer as well as other delegates and a practical workshop session to optimise learning. Benefits of attending: Certifications: Key Topics Covered: Day 1 Pharmaceutical Medicine and Documents FDA History and Organisation Legal Basis (Patent Exclusivity PDUFA, GDUFA, BsUFA) Legal Basis Continued Application and Submissions Types Refusal to File Investigational New Drug (IND) Applications Getting Products to the Market Faster FDA Meetings and Documentation CTD Content - Setting the Scene CTD Content - M1 Day 2 CTD Content - M3 and Corresponding M2 CTD Content - M4 and Corresponding M2 CTD Content - M5 and Corresponding M2 Submission Format and Methods US Amendment Procedures High Level Comparison US vs EU Case Study For more information about this training visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: FDA PHARMACEUTICAL HEALTH SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 05/20/2025 08:25 AM/DISC: 05/20/2025 08:24 AM
