LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis

Shots: The NMPA has approved Enstilar (calcipotriene/betamethasone dipropionate) for the treatment of adult patients with plaque psoriasis in China. Following NMPA approval, Enstilar is planned to launch in China later this year NMPA approval was backed by a P-III trial (n=604) in Chinese adults with plaque psoriasis, where QD Enstilar showed superior efficacy and met…

ByDipanshu Dixit8 hours ago

NEWS

Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing

Shots: Piramal Pharma Solutions has entered into a strategic collaboration with Ajinomoto Bio-Pharma Services to support antibody-drug conjugate (ADC) development and manufacturing programs Under the agreement, Piramal will refer customers to Ajinomoto’s AJICAP platform for site-specific ADC conjugation, while Ajinomoto will direct clients to Piramal for CDMO manufacturing services across development and commercialization The collaboration…

ByDipanshu Dixit9 hours ago

NEWS

Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Shots: Swissmedic has approved Vimkunya (recombinant, adsorbed) for active immunization against CHIKV disease in individuals (≥12yrs.) Vimkunya is a single-dose, prefilled VLP-based chikungunya vaccine for individuals ≥12 years, designed to trigger rapid immunity with responses starting as early as 1 week Bavarian Nordic has submitted a Health Canada application, with potential chikungunya vaccine approval in…

ByDipanshu Dixit12 hours ago

NEWS

Radiopharm Completes Final Patient Dosing of RAD 101 for Diagnosis of Brain Metastases in the US

Shots: Radiopharm Theranostics has reported that the final patient has been dosed in its US P-IIb imaging trial of RAD 101, evaluating recurrent brain metastases in patients with solid tumors. 1EP readout is expected in Jun’26, with plans to advance RAD 101 into a US P-III pivotal trial The P-IIb trial is assessing 18F-RAD101 in…

ByDipanshu Dixit13 hours ago

INSIGHTS+

The US FDA New Drug Approvals in March 2026

Shots: Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact. Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…

ByDipanshu Dixit3 days ago

NEWS

Telix Partners with Regeneron to Develop and Commercialize Radiopharmaceutical Therapies for Pain in a ~$2.1B

Shots: Telix and Regeneron have entered into a collaboration to jointly develop and commercialize next-generation radiopharmaceutical therapies Telix will receive a $40M upfront from Regeneron for four initial programs, with options to expand. The companies will share commercialization costs and profits, while Telix may opt to earn up to $535M per program in development and…

ByDipanshu Dixit4 days ago

NEWS

Haisco Partners with AbbVie to Develop Novel Medicines for Pain in a ~$745M Deal

Shots: Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…

ByDipanshu Dixit4 days ago

NEWS

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, and CUPIDKids Study A & C assessed Dupixent (LD → 300mg Q2W or 200mg Q2W for…

ByDipanshu Dixit5 days ago

NEWS

Eli Lilly Launches Foundayo (Orforglipron) for Weight Loss in the US

Shots: Eli Lilly has reported that Foundayo is now available in the US, along with lifestyle intervention for obese/overweight adults with weight-related medical problems. Foundayo is now available via LillyDirect and telehealth, with US retail rollout starting today Approval was backed by the ATTAIN program, including ATTAIN-1 (n= 3127), where Foundayo showed weight loss of…

ByDipanshu Dixit5 days ago

NEWS

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…

ByDipanshu DixitApril 9, 2026

Dipanshu Dixit

LEO Pharma’s Enstilar Receives the NMPA Approval for Plaque Psoriasis

Piramal Pharma Solutions Partners with Ajinomoto Bio-Pharma Services to Advance ADC Development and Manufacturing

Bavarian Nordic Reports Swissmedic’s Approval of Vimkunya to Prevent Chikungunya

Radiopharm Completes Final Patient Dosing of RAD 101 for Diagnosis of Brain Metastases in the US

The US FDA New Drug Approvals in March 2026

Telix Partners with Regeneron to Develop and Commercialize Radiopharmaceutical Therapies for Pain in a ~$2.1B

Haisco Partners with AbbVie to Develop Novel Medicines for Pain in a ~$745M Deal

Regeneron and Sanofi Report the EC Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Eli Lilly Launches Foundayo (Orforglipron) for Weight Loss in the US

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

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