AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis

Shots: The CHMP has recommended Klygefa(gefurulimab; SC, QW) as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adults who are AChR antibody-positive; filings are under review in the US, China & other countries Opinion was supported by the P-III (PREVAIL) trial assessing Klygefavs PBO in 260 gMG adults for…

ByRidhi RastogiSeptember 21, 2026

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Grünenthal to Acquire Bayer’s Stivarga for ~€375M

Shots: Grünenthal has entered into an agreement with Bayer to acquire Stivarga for ~€375M (~$430.67M), subject to customary closing conditions incl. regulatory approval, with the transaction expected to close by the end of 2026 or early 2027 Stivarga (regorafenib) is an oral multikinase inhibitor indicated for metastatic colorectal cancer, hepatocellular carcinoma, & gastrointestinal stromal tumours…

ByRidhi RastogiSeptember 21, 2026

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mAbxience and Sandoz Partner to Advance Emicizumab Biosimilar Access Globally

Shots: mAbxience & Sandoz have entered into a licensing, development, manufacturing & commercialization agreement for an emicizumab biosimilar candidate As pe the deal, mAbxience will develop & manufacture the biosimilar at its GMP-approved facilities in Spain & Argentina, while Sandoz will hold exclusive global commercialization rights (excl. Argentina, Uruguay & Paraguay); financial terms remain confidential…

ByRidhi RastogiSeptember 21, 2026

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Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

Shots: FDA has granted full approval to Inluriyo (imlunestrant; PO) + Verzenio (abemaciclib) for treating adults with ER+, HER2-, ESR1-mutated locally advanced or metastatic breast cancer whose disease progressed after ≥1L of endocrine therapy (ET) Approval was based on the P-III (EMBER-3) trial assessing Inluriyo ± Verzenio in ESR1-mutated MBC pts (n=159); Inluriyo + Verzenio (n=67) doubled the…

ByRidhi RastogiSeptember 21, 2026

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IntraBio Reports the US FDA Approval of Aqneursa for Ataxia-Telangiectasia

Shots: The US FDA has approved Aqneursa (levacetylleucine) for the treatment of ataxia in adult & pediatric pts (≥15kg) with ataxia-telangiectasia (A-T) Approval was backed by the P-III (IB1001-303) trial assessing Aqneursa vs PBO in 73 pts (4-50yrs.) with genetically confirmed A-T, which met its 1 & key 2EPs & showed that Aqneursa has a…

ByRidhi RastogiSeptember 21, 2026

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The CHMP Recommends Novo’s Frehemgo (Denecimig) for Haemophilia A

Shots: The CHMP has recommended Frehemgo (QM, Q2W or QW) to treat haemophilia A, with or without inhibitors, in adults & children, based on the FRONTIER program; launch is expected in the first EU countries in Q4’26 & broadly across the EU starting early 2027 FRONTIER 2 trial showed Frehemgo significantly reduced annualized bleeding rates…

ByRidhi RastogiSeptember 18, 2026

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Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

Shots: The CHMP has recommended Padcev (enfortumab vedotin) + Keytruda for neoadj. & adj. treatment for pts with resectable muscle-invasive bladder cancer (MIBC); if approved, authorization would be valid in all 30 EEA states Opinion was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj.…

ByRidhi RastogiSeptember 18, 2026

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1ST Biotherapeutics Inks ~$314.8M Deal with SK Biopharmaceuticals for 1ST-104

Shots: 1ST Biotherapeutics SK Biopharmaceuticals have entered into an exclusive global licensing agreement & strategic equity investment partnership to advance 1ST-104 for the treatment of Parkinson's disease As per the deal, 1STBIO will receive a $1.8M upfront payment, with the licensing agreement valued at ~$314.8M, incl. a $1.8M short-term milestone upon candidate selection & additional…

ByRidhi RastogiSeptember 18, 2026

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Nuvation Bio Reports US FDA Approval of Ibtrozi for ROS1+ NSCLC

Shots: The US FDA has approved an sNDA for Ibtrozi (taletrectinib) for the treatment of locally advanced or metastatic ROS1-positive NSCLC, 4mos. ahead of its PDUFA target action date Updated Ibtrozi label reports a mDoR of 49.7mos. in TKI-naïve TRUST-I pts, with no new safety signals; based on 51mos. of mFU & an additional 14mos.…

ByRidhi RastogiSeptember 18, 2026

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The US FDA Approves Ultragenyx’s Fayuvi for Sanfilippo Syndrome Type A

Shots: The FDA has granted full approval to Fayuvi (rebisufligene etisparvovec-hopf) for pediatric pts with Sanfilippo syndrome Type A, plus a Priority Review Voucher; commercial product will be available for shipment to QTCs within 30-60 days Approval was supported by pivotal Transpher A & long-term follow-up data, where Fayuvi-treated pts from the mITT population (n=17)…

ByRidhi RastogiSeptember 18, 2026

Ridhi Rastogi

AstraZeneca Reports the CHMP Positive Opinion for Klygefa to Treat Generalised Myasthenia Gravis

Grünenthal to Acquire Bayer’s Stivarga for ~€375M

mAbxience and Sandoz Partner to Advance Emicizumab Biosimilar Access Globally

Eli Lilly Receives Full FDA Approval for Inluriyo + Verzenio to Treat ESR1-mutated Breast Cancer

IntraBio Reports the US FDA Approval of Aqneursa for Ataxia-Telangiectasia

The CHMP Recommends Novo’s Frehemgo (Denecimig) for Haemophilia A

Astellas Secures the CHMP Positive Opinion for Perioperative Padcev + Keytruda in MIBC Patients

1ST Biotherapeutics Inks ~$314.8M Deal with SK Biopharmaceuticals for 1ST-104

Nuvation Bio Reports US FDA Approval of Ibtrozi for ROS1+ NSCLC

The US FDA Approves Ultragenyx’s Fayuvi for Sanfilippo Syndrome Type A

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